17 Medical Researchers jobs in Toronto

Job Description

Job Description

Position Summary:

We are seeking a motivated and detail-oriented Clinical Research Coordinator (CRC) to manage and coordinate clinical research studies in accordance with Good Clinical Practice (GCP), institutional guidelines, and federal regulations. The CRC will work closely with investigators, sponsors, and participants to ensure the integrity of study protocols and data collection.

Key Responsibilities:

• Coordinate and conduct all aspects of clinical research studies, including participant recruitment, consent, scheduling, and follow-up.
• Ensure compliance with study protocols and regulatory requirements (Health Canada, IRB, ICH-GCP).
• Collect and enter data accurately into electronic data capture (EDC) systems.
• Maintain study documents, including electronic regulatory binders, subject files, and case report forms.
• Monitor and report adverse events and ensure timely communication with the IRB and sponsors.
• Prepare for and participate in monitoring visits, audits, and inspections.
• Collaborate with cross-functional teams, including principal investigators, sponsors, and other research personnel.

Qualifications:

• Bachelor’s degree in health sciences, life sciences, nursing, or a related field (required).
• Minimum (1-3) years of experience in clinical research (preferred).
• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) a plus.
• Phlebotomy certification and proficiency in drawing with ability to process and ship per IATA requirements.
• Strong knowledge of GCP, Health Canada, and IRB regulations.
• Excellent organizational, communication, and problem-solving skills.
• Proficiency with EDC systems (e.g., Medidata, or RAVE) and Microsoft Office Suite.

Work Environment:

• On-site in physician practice and clinical research setting.
• May require handling of biological samples and/or working with patients.

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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
**Purpose:**
Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Clinical Research Scientist - Clinical Development: Neuropsychologist is an integral member of the Neuroscience medical development team and participates in: the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product; the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization.
The Clinical Research Scientist must be aware of and ensure that all their activities are in compliance with current local and international regulations, laws, guidance's (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision.
**Overall Responsibilities** **:**
With the expansion of the Lilly portfolio, this role will be responsible for scientific support for clinical trials across the Neuroscience platform and serves a spectrum of patients with neurological and psychiatric conditions. The clinical research scientist is a scientific resource for study teams, departments, and others as needed, particularly pertaining to the selection of clinical trial endpoints, the implementation and central monitoring strategy of clinical endpoints and the translation of clinical trial outcome data into meaningful benefits. This includes, but is not limited to, design and execution of phase 2/3 studies to address the needs of the commercial organization.
The ideal candidate will be a critical thinker and understand Neuroscience, Neuropsychology, neuropsychological assessment and measurement science.
**Specific responsibilities may include but are not limited to:**
**Clinical Planning**
+ Collaborate with the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans and study protocol design.
+ Contribute to business unit and global alignment of clinical strategy and clinical plans.
+ Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
**Clinical Research/Trial/ Execution and Support**
+ Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports) according to the agreed upon project timeline.
+ Provide protocol oversight and input into informed consent documents.
+ Supports the monitoring of patient safety during study and participates in the global product safety reviews including the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.
+ Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).
+ Review and collaborates with CRP on the approval of risk profiles to ensure appropriate communication of risk to study subjects.
+ Participate in investigator identification and selection, in conjunction with clinical teams.
+ Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
+ Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
+ Serve as resource to clinical operations/CTMs/ clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
+ Understand and actively address the scientific information needs of all investigators and personnel.
+ Review lIT proposals and publications, as requested by CRP or Director-Medical.
**Scientific Data Dissemination/Exchange**
+ Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals.
+ Understand and address the unsolicited scientific information needs of external health care professionals according to guidelines above.
+ Participate in reporting of clinical trial data in Clinical Trial Registry activities.
+ Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
+ Prepare or review scientific information in response to customer questions or media requests
+ Provide telephone follow-up or specific written information requested by health care professionals as per global SOPs.
+ Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis.
+ Support the design of customer research as medical expert
+ Support medical information associates in preparation and review of medical letters and other medical information materials.
+ Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).
+ Develop and maintain appropriate collaborations and relationships with relevant professional societies.
+ Support training of medical personnel, including geographic/affiliate medical personnel as assigned, medical and outcome liaisons and global patient outcomes personnel.
+ Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events)
+ Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.
**Regulatory Support Activities**
+ Participate in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal.
+ Provide medical expertise to regulatory scientists.
+ Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective.
+ Participate in advisory committees.
+ Participate in risk management planning along with affiliates and Global Patient Safety (GPS).
**Scientific I Technical Expertise and continued development**
+ Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product
+ Responsible for the scientific training of the clinical study team.
+ Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
+ Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer term (3-5 years).
+ Explore and take advantage of opportunities for extramural scientific experiences
+ Attend, contribute and participate in scientific symposia, as well as administrative/business workshops and training.
**General Responsibilities**
+ Actively set and meet individual professional development goals and contribute to the development of others.
+ Support the management team, including the Sr. Director-Medical, in preparation and administration of the business unit development budget.
+ Actively participate in recruitment, diversity and retention efforts.
+ Collaborate proactively and productively with all alliance, business and vendor partners.
+ Participate in active coaching by providing timely and constructive feedback to co-workers, others on the medical team, in the spirit of development, increased team effectiveness and cohesiveness.
+ Participate in committees, process improvement initiatives and task forces as requested by local/corporate management
+ Ensures that at all times is adequately qualified and trained in the tasks required to perform. Includes accountability and compliance for maintaining a current curriculum training map for self.
+ Model the leadership behaviors
+ Be an ambassador of both patients and the Lilly Brand
**Basic Requirements:**
+ Doctoral level Degree (Ph.D, Psy.D or equivalent) in Clinical Neuropsychology with 2+ years industry or academic experience beyond any postdoctoral positions.
+ Demonstrated experience in clinical and/or research settings in working with adults with neurological and/or psychiatric disorders
+ Clinical experience in conducting assessments and administering standardized scales within a clinical and/or research context.
+ Experience and agility in the conduct and interpretation of statistical and psychometric analyses
+ Evidence of scientific track record in publications, conference presentations
**Additional Information:**
+ Fluent in English, written and verbal communications
+ Ability to engage in occasional domestic and international travel to the degree appropriate to support the business of the team.
+ Position Location - Indianapolis, IN or Remote
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$142,500 - $228,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly

IQVIA est à la recherche d'un associé de recherche clinique II avec une expérience en surveillance en oncologie basé dans l'Est du Canada. Doit être bilingue en français et en anglais.
**Aperçu du poste**
Surveiller et gérer les centres pour s'assurer qu'ils réalisent les études et produisent des rapports sur les données d'étude conformément au protocole d'étude, aux règlements et aux lignes directrices applicables, et aux exigences du promoteur.
**Fonctions essentielles**
+ Effectuer des visites de surveillance du centre (visites de sélection, d'initiation, de surveillance et de clôture) conformément à la portée des travaux indiquée au contrat et aux bonnes pratiques cliniques.
+ Travailler avec les centres pour adapter, piloter et suivre le plan de recrutement des sujets conformément aux besoins du projet afin d'améliorer la prévisibilité.
+ Administrer le protocole et la formation sur les études connexe dans les centres assignés et établir régulièrement la communication avec les centres pour gérer les attentes et les problèmes en cours de projet.
+ Évaluer la qualité et l'intégrité des pratiques du centre d'étude liées au bon déroulement du protocole et au respect de la réglementation applicable. Signaler les problèmes de qualité, le cas échéant.
+ Gérer l'avancement des études assignées en suivant les soumissions et les approbations réglementaires, le recrutement et l'inscription, l'achèvement et la soumission du cahier d'observation (CRF), ainsi que la production et la résolution des requêtes de données. Apporter son appui pendant la phase de démarrage, au besoin.
+ S'assurer que les copies/originaux (selon les besoins) des documents du centre sont ajoutés au dossier principal d'essai (DPE) et vérifier que le dossier du centre de l'investigateur (DCI) est conservé conformément aux BPC et aux exigences réglementaires locales.
+ Créer et maintenir une documentation appropriée concernant la gestion du centre, les résultats des visites de surveillance et les plans d'action en soumettant des rapports de visite réguliers, en générant des lettres de suivi et d'autres documents d'étude requis.
+ Collaborer et assurer la liaison avec les membres de l'équipe de l'étude pour le soutien à l'exécution du projet, le cas échéant.
+ Le cas échéant, soutenir l'élaboration du plan de recrutement des sujets du projet pour un centre donné.
+ Le cas échéant, superviser la gestion financière du centre conformément à l'accord d'essai clinique signé et récupérer les factures conformément aux exigences locales.
**Diplômes et expérience**
+ Baccalauréat dans une discipline scientifique ou en soins de santé exigé
+ Au moins 2 ans d'expérience en surveillance sur place.
+ Une combinaison équivalente d'études, de formation et d'expérience peut aussi être acceptée.
+ Bonne connaissance et aptitude à appliquer les exigences réglementaires applicables en matière de recherche clinique.
+ C'est-à-dire les lignes directrices des bonnes pratiques cliniques (BPC) et du Conseil international d'harmonisation (CIH).
+ Bonne connaissance des thérapies et protocoles, tels que présentés dans la formation en entreprise.
+ Compétences informatiques, y compris la maîtrise de Microsoft Word, Excel et PowerPoint et de l'utilisation d'un ordinateur portable ainsi que d'un iPhone et d'un iPad (le cas échéant).
+ Maîtrise écrite et verbale de l'anglais et du français
+ Solides compétences en matière d'organisation et de résolution de problèmes.
+ Gestion efficace du temps et des finances.
+ Capacité à établir et à entretenir des relations de travail efficaces avec les collègues, les gestionnaires et les clients.
+ Vous devrez soutenir, assurer la liaison avec et/ou travailler avec des (clients et/ou fournisseurs) d'IQVIA partout au Canada et à travers le monde, par conséquent, une connaissance fonctionnelle de l'anglais, tant à l'écrit qu'à l'oral, est nécessaire à l'exercice des fonctions de ce poste.
___
English:
IQVIA is seeking a Clinical Research Associate II with Oncology monitoring experience based in Eastern Canada. Must be bilingual in French and English.
**BASIC FUNCTIONS:**
Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. This position may also serve as Lead CRA.
**II ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**
+ Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
+ Collaborates with the ISSC department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISSC and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
+ Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
+ Trains site staff on the EDC system and verifies site computer system.
+ Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISSC.
+ Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.
+ Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
+ Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.
+ Perform SAE review and reconciliation
+ May review protocols, eCRFs, study manuals and other related documents, as requested by Clinical Trial Manager and/or Lead CRA.
+ Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
+ Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
+ May assist with, and attend, Investigator Meetings for assigned studies.
+ Attends study-related, company, departmental, and external meetings, as required.
+ May serve as mentor for new clinical study monitors.
+ Authorized to request site audits due to data integrity concerns.
+ Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.
+ Ensure all study deliverables are completed per IQVIA Biotech and study timelines.
**LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**
The Lead Clinical Research Associate **may** perform any of the following tasks:
+ Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
+ Collaborate with the ISSC department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISSC and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
+ Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
+ Assists with, and attends, Investigator Meetings for assigned studies.
+ Train site staff on the EDC system and verify site computer system.
+ Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISSC.
+ Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.
+ Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
+ Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries.
+ May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM.
+ May serve as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
+ Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.
+ Assist the study management in identifying and generating changes in scope
+ Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
+ Authorized to request site audits due to data integrity concerns.
+ Attend study-related, company, departmental, and external meetings, as required.
+ Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.
+ Ensure all study deliverables are completed per IQVIA Biotech and study timelines
+ Conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs.
+ Serve as mentor for junior CRAs and those new to the company and/or study.
+ Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA.
+ Review and approve CRA travel expenses and time sheets.
+ Perform other duties, as requested.
**KNOWLEDGE, SKILLS AND ABILITIES:**
+ Knowledge of clinical research process and medical terminology.
+ Strong written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
+ Good organizational and interpersonal skills.
+ Ability to reason independently and recommend specific solutions in clinical settings.
+ Ability to understand electronic data capture including basic data processing functions.
+ Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.
+ Ability to qualify for a major credit card, rent an automobile
**PHYSICAL REQUIREMENTS:**
+ Very limited physical effort required to perform normal job duties
+ Extensive use of telephone and face-to-face communication requiring accurate perception of speech
+ Extensive use of keyboard requiring repetitive motion of fingers
+ Regular sitting for extended periods of time
**MINIMUM RECRUITMENT STANDARDS:**
+ BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc.) and a minimum of two (2) years of monitoring/site management experience is required; or an equivalent combination of education, training and experience.
+ Must possess 2+ years of oncology and/or medical device experience.
+ Experience in monitoring and/or coordinating clinical trials required.
+ Must be able to travel domestically approximately 65%-85%.
+ Valid driver's license
+ Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
+ You will be required to support, liaise with and/or work with IQVIA customers and/or suppliers across Canada and around the world therefore, a functional knowledge of English, both written and spoken, is necessary to perform the duties of this position.
Comme nos équipes de recrutement sont mondiales, veuillez soumettre votre CV en anglais et en français.
As our hiring teams are global, please submit your resume in both English and French.
IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé. IQVIA se consacre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus, visitez est fière d'être un employeur souscrivant au principe de l'égalité d'accès à l'emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l'orientation sexuelle, l'identité de genre, l'origine nationale, le handicap, l'âge, l'état matrimonial ou tout autre statut protégé par la loi applicable. Des mesures d'adaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui nécessite une mesure d'adaptation, nous vous encourageons à contacter notre équipe d'acquisition de talents au , afin qu'IQVIA puisse soutenir votre participation au processus de recrutement.
Veuillez noter qu'il est possible que nous utilisions l'intelligence artificielle (IA) dans le traitement de votre candidature. Cependant, nous utilisons l'IA uniquement pour aider notre équipe de recrutement à sélectionner ou à évaluer les candidatures, et non pas pour remplacer la prise des décisions par les membres de notre équipe.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, or any other status protected by applicable law. Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request. If you have a disability that requires an accommodation, we encourage you to contact our Talent Acquisition Team at: , so that IQVIA can support your participation in the recruitment process.
Please note that we may use artificial intelligence (AI) in the processing of your application. However, we only use AI to assist our recruitment team with the screening or assessment of candidacies, and not as a substitute for human decision-making.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled

**French:** Pour être éligible à ce poste, vous devez résider dans le même pays où se trouve le poste.
IQVIA Biotech est à la recherche d'un associé de recherche clinique II avec une expérience en surveillance en oncologie basé dans l'Est du Canada. Doit être bilingue en français et en anglais.
**Aperçu du poste**
Surveiller et gérer les centres pour s'assurer qu'ils réalisent les études et produisent des rapports sur les données d'étude conformément au protocole d'étude, aux règlements et aux lignes directrices applicables, et aux exigences du promoteur.
**Fonctions essentielles**
+ Effectuer des visites de surveillance du centre (visites de sélection, d'initiation, de surveillance et de clôture) conformément à la portée des travaux indiquée au contrat et aux bonnes pratiques cliniques.
+ Travailler avec les centres pour adapter, piloter et suivre le plan de recrutement des sujets conformément aux besoins du projet afin d'améliorer la prévisibilité.
+ Administrer le protocole et la formation sur les études connexe dans les centres assignés et établir régulièrement la communication avec les centres pour gérer les attentes et les problèmes en cours de projet.
+ Évaluer la qualité et l'intégrité des pratiques du centre d'étude liées au bon déroulement du protocole et au respect de la réglementation applicable. Signaler les problèmes de qualité, le cas échéant.
+ Gérer l'avancement des études assignées en suivant les soumissions et les approbations réglementaires, le recrutement et l'inscription, l'achèvement et la soumission du cahier d'observation (CRF), ainsi que la production et la résolution des requêtes de données. Apporter son appui pendant la phase de démarrage, au besoin.
+ S'assurer que les copies/originaux (selon les besoins) des documents du centre sont ajoutés au dossier principal d'essai (DPE) et vérifier que le dossier du centre de l'investigateur (DCI) est conservé conformément aux BPC et aux exigences réglementaires locales.
+ Créer et maintenir une documentation appropriée concernant la gestion du centre, les résultats des visites de surveillance et les plans d'action en soumettant des rapports de visite réguliers, en générant des lettres de suivi et d'autres documents d'étude requis.
+ Collaborer et assurer la liaison avec les membres de l'équipe de l'étude pour le soutien à l'exécution du projet, le cas échéant.
+ Le cas échéant, soutenir l'élaboration du plan de recrutement des sujets du projet pour un centre donné.
+ Le cas échéant, superviser la gestion financière du centre conformément à l'accord d'essai clinique signé et récupérer les factures conformément aux exigences locales.
**Diplômes et expérience**
+ Baccalauréat dans une discipline scientifique ou en soins de santé exigé
+ Au moins 2 ans d'expérience en surveillance sur place.
+ Une combinaison équivalente d'études, de formation et d'expérience peut aussi être acceptée.
+ Bonne connaissance et aptitude à appliquer les exigences réglementaires applicables en matière de recherche clinique.
+ C'est-à-dire les lignes directrices des bonnes pratiques cliniques (BPC) et du Conseil international d'harmonisation (CIH).
+ Bonne connaissance des thérapies et protocoles, tels que présentés dans la formation en entreprise.
+ Compétences informatiques, y compris la maîtrise de Microsoft Word, Excel et PowerPoint et de l'utilisation d'un ordinateur portable ainsi que d'un iPhone et d'un iPad (le cas échéant).
+ Maîtrise écrite et verbale de l'anglais et du français
+ Solides compétences en matière d'organisation et de résolution de problèmes.
+ Gestion efficace du temps et des finances.
+ Capacité à établir et à entretenir des relations de travail efficaces avec les collègues, les gestionnaires et les clients.
+ Vous devrez soutenir, assurer la liaison avec et/ou travailler avec des (clients et/ou fournisseurs) d'IQVIA partout au Canada et à travers le monde, par conséquent, une connaissance fonctionnelle de l'anglais, tant à l'écrit qu'à l'oral, est nécessaire à l'exercice des fonctions de ce poste.
___
**English:** To be eligible for this position, you must reside in the same country where the job is located.
IQVIA Biotech is seeking a Clinical Research Associate II with Oncology monitoring experience based in Eastern Canada. Must be bilingual in French and English.
**BASIC FUNCTIONS:**
Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. This position may also serve as Lead CRA.
**II ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**
+ Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
+ Collaborates with the ISSC department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISSC and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
+ Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
+ Trains site staff on the EDC system and verifies site computer system.
+ Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISSC.
+ Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.
+ Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
+ Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.
+ Perform SAE review and reconciliation
+ May review protocols, eCRFs, study manuals and other related documents, as requested by Clinical Trial Manager and/or Lead CRA.
+ Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
+ Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
+ May assist with, and attend, Investigator Meetings for assigned studies.
+ Attends study-related, company, departmental, and external meetings, as required.
+ May serve as mentor for new clinical study monitors.
+ Authorized to request site audits due to data integrity concerns.
+ Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.
+ Ensure all study deliverables are completed per IQVIA Biotech and study timelines.
**LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**
The Lead Clinical Research Associate **may** perform any of the following tasks:
+ Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
+ Collaborate with the ISSC department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISSC and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
+ Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
+ Assists with, and attends, Investigator Meetings for assigned studies.
+ Train site staff on the EDC system and verify site computer system.
+ Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISSC.
+ Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.
+ Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
+ Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries.
+ May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM.
+ May serve as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
+ Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.
+ Assist the study management in identifying and generating changes in scope
+ Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
+ Authorized to request site audits due to data integrity concerns.
+ Attend study-related, company, departmental, and external meetings, as required.
+ Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.
+ Ensure all study deliverables are completed per IQVIA Biotech and study timelines
+ Conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs.
+ Serve as mentor for junior CRAs and those new to the company and/or study.
+ Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA.
+ Review and approve CRA travel expenses and time sheets.
+ Perform other duties, as requested.
**KNOWLEDGE, SKILLS AND ABILITIES:**
+ Knowledge of clinical research process and medical terminology.
+ Strong written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
+ Good organizational and interpersonal skills.
+ Ability to reason independently and recommend specific solutions in clinical settings.
+ Ability to understand electronic data capture including basic data processing functions.
+ Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.
+ Ability to qualify for a major credit card, rent an automobile
**PHYSICAL REQUIREMENTS:**
+ Very limited physical effort required to perform normal job duties
+ Extensive use of telephone and face-to-face communication requiring accurate perception of speech
+ Extensive use of keyboard requiring repetitive motion of fingers
+ Regular sitting for extended periods of time
**MINIMUM RECRUITMENT STANDARDS:**
+ BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc.) and a minimum of two (2) years of monitoring/site management experience is required; or an equivalent combination of education, training and experience.
+ Must possess 2+ years of oncology and/or medical device experience.
+ Experience in monitoring and/or coordinating clinical trials required.
+ Must be able to travel domestically approximately 65%-85%.
+ Valid driver's license
+ Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
+ You will be required to support, liaise with and/or work with IQVIA customers and/or suppliers across Canada and around the world therefore, a functional knowledge of English, both written and spoken, is necessary to perform the duties of this position.
Comme nos équipes de recrutement sont mondiales, veuillez soumettre votre CV en anglais et en français.
As our hiring teams are global, please submit your resume in both English and French.
IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé. IQVIA se consacre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus, visitez est fière d'être un employeur souscrivant au principe de l'égalité d'accès à l'emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l'orientation sexuelle, l'identité de genre, l'origine nationale, le handicap, l'âge, l'état matrimonial ou tout autre statut protégé par la loi applicable. Des mesures d'adaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui nécessite une mesure d'adaptation, nous vous encourageons à contacter notre équipe d'acquisition de talents au , afin qu'IQVIA puisse soutenir votre participation au processus de recrutement.
Veuillez noter qu'il est possible que nous utilisions l'intelligence artificielle (IA) dans le traitement de votre candidature. Cependant, nous utilisons l'IA uniquement pour aider notre équipe de recrutement à sélectionner ou à évaluer les candidatures, et non pas pour remplacer la prise des décisions par les membres de notre équipe.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, or any other status protected by applicable law. Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request. If you have a disability that requires an accommodation, we encourage you to contact our Talent Acquisition Team at: , so that IQVIA can support your participation in the recruitment process.
Please note that we may use artificial intelligence (AI) in the processing of your application. However, we only use AI to assist our recruitment team with the screening or assessment of candidacies, and not as a substitute for human decision-making.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled

**French:** Pour être éligible à ce poste, vous devez résider dans le même pays où se trouve le poste.
IQVIA Biotech est à la recherche d'un associé de recherche clinique II avec une expérience en surveillance en oncologie basé dans l'Est du Canada. Doit être bilingue en français et en anglais.
**Aperçu du poste**
Surveiller et gérer les centres pour s'assurer qu'ils réalisent les études et produisent des rapports sur les données d'étude conformément au protocole d'étude, aux règlements et aux lignes directrices applicables, et aux exigences du promoteur.
**Fonctions essentielles**
+ Effectuer des visites de surveillance du centre (visites de sélection, d'initiation, de surveillance et de clôture) conformément à la portée des travaux indiquée au contrat et aux bonnes pratiques cliniques.
+ Travailler avec les centres pour adapter, piloter et suivre le plan de recrutement des sujets conformément aux besoins du projet afin d'améliorer la prévisibilité.
+ Administrer le protocole et la formation sur les études connexe dans les centres assignés et établir régulièrement la communication avec les centres pour gérer les attentes et les problèmes en cours de projet.
+ Évaluer la qualité et l'intégrité des pratiques du centre d'étude liées au bon déroulement du protocole et au respect de la réglementation applicable. Signaler les problèmes de qualité, le cas échéant.
+ Gérer l'avancement des études assignées en suivant les soumissions et les approbations réglementaires, le recrutement et l'inscription, l'achèvement et la soumission du cahier d'observation (CRF), ainsi que la production et la résolution des requêtes de données. Apporter son appui pendant la phase de démarrage, au besoin.
+ S'assurer que les copies/originaux (selon les besoins) des documents du centre sont ajoutés au dossier principal d'essai (DPE) et vérifier que le dossier du centre de l'investigateur (DCI) est conservé conformément aux BPC et aux exigences réglementaires locales.
+ Créer et maintenir une documentation appropriée concernant la gestion du centre, les résultats des visites de surveillance et les plans d'action en soumettant des rapports de visite réguliers, en générant des lettres de suivi et d'autres documents d'étude requis.
+ Collaborer et assurer la liaison avec les membres de l'équipe de l'étude pour le soutien à l'exécution du projet, le cas échéant.
+ Le cas échéant, soutenir l'élaboration du plan de recrutement des sujets du projet pour un centre donné.
+ Le cas échéant, superviser la gestion financière du centre conformément à l'accord d'essai clinique signé et récupérer les factures conformément aux exigences locales.
**Diplômes et expérience**
+ Baccalauréat dans une discipline scientifique ou en soins de santé exigé
+ Au moins 2 ans d'expérience en surveillance sur place.
+ Une combinaison équivalente d'études, de formation et d'expérience peut aussi être acceptée.
+ Bonne connaissance et aptitude à appliquer les exigences réglementaires applicables en matière de recherche clinique.
+ C'est-à-dire les lignes directrices des bonnes pratiques cliniques (BPC) et du Conseil international d'harmonisation (CIH).
+ Bonne connaissance des thérapies et protocoles, tels que présentés dans la formation en entreprise.
+ Compétences informatiques, y compris la maîtrise de Microsoft Word, Excel et PowerPoint et de l'utilisation d'un ordinateur portable ainsi que d'un iPhone et d'un iPad (le cas échéant).
+ Maîtrise écrite et verbale de l'anglais et du français
+ Solides compétences en matière d'organisation et de résolution de problèmes.
+ Gestion efficace du temps et des finances.
+ Capacité à établir et à entretenir des relations de travail efficaces avec les collègues, les gestionnaires et les clients.
+ Vous devrez soutenir, assurer la liaison avec et/ou travailler avec des (clients et/ou fournisseurs) d'IQVIA partout au Canada et à travers le monde, par conséquent, une connaissance fonctionnelle de l'anglais, tant à l'écrit qu'à l'oral, est nécessaire à l'exercice des fonctions de ce poste.
___
**English:** To be eligible for this position, you must reside in the same country where the job is located.
IQVIA Biotech is seeking a Clinical Research Associate II with Oncology monitoring experience based in Eastern Canada. Must be bilingual in French and English.
**BASIC FUNCTIONS:**
Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. This position may also serve as Lead CRA.
**II ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**
+ Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
+ Collaborates with the ISSC department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISSC and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
+ Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
+ Trains site staff on the EDC system and verifies site computer system.
+ Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISSC.
+ Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.
+ Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
+ Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.
+ Perform SAE review and reconciliation
+ May review protocols, eCRFs, study manuals and other related documents, as requested by Clinical Trial Manager and/or Lead CRA.
+ Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
+ Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
+ May assist with, and attend, Investigator Meetings for assigned studies.
+ Attends study-related, company, departmental, and external meetings, as required.
+ May serve as mentor for new clinical study monitors.
+ Authorized to request site audits due to data integrity concerns.
+ Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.
+ Ensure all study deliverables are completed per IQVIA Biotech and study timelines.
**LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**
The Lead Clinical Research Associate **may** perform any of the following tasks:
+ Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
+ Collaborate with the ISSC department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISSC and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
+ Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
+ Assists with, and attends, Investigator Meetings for assigned studies.
+ Train site staff on the EDC system and verify site computer system.
+ Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISSC.
+ Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.
+ Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
+ Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries.
+ May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM.
+ May serve as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
+ Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.
+ Assist the study management in identifying and generating changes in scope
+ Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
+ Authorized to request site audits due to data integrity concerns.
+ Attend study-related, company, departmental, and external meetings, as required.
+ Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.
+ Ensure all study deliverables are completed per IQVIA Biotech and study timelines
+ Conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs.
+ Serve as mentor for junior CRAs and those new to the company and/or study.
+ Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA.
+ Review and approve CRA travel expenses and time sheets.
+ Perform other duties, as requested.
**KNOWLEDGE, SKILLS AND ABILITIES:**
+ Knowledge of clinical research process and medical terminology.
+ Strong written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
+ Good organizational and interpersonal skills.
+ Ability to reason independently and recommend specific solutions in clinical settings.
+ Ability to understand electronic data capture including basic data processing functions.
+ Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.
+ Ability to qualify for a major credit card, rent an automobile
**PHYSICAL REQUIREMENTS:**
+ Very limited physical effort required to perform normal job duties
+ Extensive use of telephone and face-to-face communication requiring accurate perception of speech
+ Extensive use of keyboard requiring repetitive motion of fingers
+ Regular sitting for extended periods of time
**MINIMUM RECRUITMENT STANDARDS:**
+ BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc.) and a minimum of two (2) years of monitoring/site management experience is required; or an equivalent combination of education, training and experience.
+ Must possess 2+ years of oncology and/or medical device experience.
+ Experience in monitoring and/or coordinating clinical trials required.
+ Must be able to travel domestically approximately 65%-85%.
+ Valid driver's license
+ Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
+ You will be required to support, liaise with and/or work with IQVIA customers and/or suppliers across Canada and around the world therefore, a functional knowledge of English, both written and spoken, is necessary to perform the duties of this position.
Comme nos équipes de recrutement sont mondiales, veuillez soumettre votre CV en anglais et en français.
As our hiring teams are global, please submit your resume in both English and French.
IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé. IQVIA se consacre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus, visitez est fière d'être un employeur souscrivant au principe de l'égalité d'accès à l'emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l'orientation sexuelle, l'identité de genre, l'origine nationale, le handicap, l'âge, l'état matrimonial ou tout autre statut protégé par la loi applicable. Des mesures d'adaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui nécessite une mesure d'adaptation, nous vous encourageons à contacter notre équipe d'acquisition de talents au , afin qu'IQVIA puisse soutenir votre participation au processus de recrutement.
Veuillez noter qu'il est possible que nous utilisions l'intelligence artificielle (IA) dans le traitement de votre candidature. Cependant, nous utilisons l'IA uniquement pour aider notre équipe de recrutement à sélectionner ou à évaluer les candidatures, et non pas pour remplacer la prise des décisions par les membres de notre équipe.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, or any other status protected by applicable law. Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request. If you have a disability that requires an accommodation, we encourage you to contact our Talent Acquisition Team at: , so that IQVIA can support your participation in the recruitment process.
Please note that we may use artificial intelligence (AI) in the processing of your application. However, we only use AI to assist our recruitment team with the screening or assessment of candidacies, and not as a substitute for human decision-making.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled

**Fonction : Associé(e) de recherche clinique (ARC) principal(e) 2**
**Vue d'ensemble du poste**
Effectuer des tâches de suivi et de gestion de site pour une variété de protocoles, de sites et de domaines thérapeutiques. Doit être bilingue français et anglais et situé à Montréal.
**Responsabilités essentielles**
- Effectuer des visites de suivi des sites (visites de sélection, de lancement, de suivi et de clôture) conformément à la portée contractuelle des travaux et les exigences réglementaires, c'est-à-dire les directives de pratiques exemplaires cliniques (BPC) et de la Conférence internationale sur l'harmonisation (ICH).
- Travailler avec les sites pour adapter, mener et suivre les plans de recrutement des sujets conformément aux besoins du projet afin d'améliorer la prévisibilité.
- Gérer la formation liée au protocole et à l'étude pour les sites assignés et maintenir une communication régulière avec les sites pour gérer les attentes et les problèmes des projets en cours.
- Évaluer la qualité et l'intégrité des pratiques du site d'étude liées au bon déroulement du protocole et au respect de la réglementation applicable. Soumettre les problèmes de qualité à l'échelon supérieur, le cas échéant.
- Gérer l'avancement des études assignées en suivant les soumissions et approbations réglementaires, le recrutement et l'inscription, l'achèvement et la soumission du cahier d'observation, ainsi que la génération et la résolution des requêtes de données. Peut soutenir la phase de lancement.
- S'assurer que les copies/originaux (comme requis) des documents du site sont disponibles pour être classé(e)s dans le dossier permanent de l'essai (DPE) et vérifier que le dossier de l'investigateur du site (DIC) est tenu conformément aux directives GCP/ICH et aux exigences réglementaires locales.
- Créer et tenir la documentation appropriée concernant la gestion de site, les résultats des visites de suivi et les plans d'action en soumettant des rapports de visite réguliers, et en générant des lettres de suivi et d'autres documents d'étude requis.
- Servir de mentor pour le personnel clinique, notamment par des visites de cosuivi et de formation.
- Collaborer et assurer la liaison avec les membres de l'équipe de l'étude pour le soutien à l'exécution du projet, au besoin.
- Le cas échéant, peut être responsable de soutenir l'élaboration du plan de recrutement des sujets du projet pour chaque site.
- Le cas échéant, peut être responsable de la gestion financière du site conformément à l'accord d'essai clinique signé et récupérer les factures conformément aux exigences locales.
**Diplômes et expérience requise**
- Baccalauréat dans une discipline scientifique ou en soins de santé de privilégié. Requis
- Nécessite au moins 3 ans d'expérience en surveillance sur site.
- Une combinaison équivalente d'études, de formation et d'expérience peut être acceptée à la place d'un diplôme.
- Connaissance approfondie et aptitude à appliquer les exigences réglementaires applicables en matière de recherche clinique, c'est-à-dire les lignes directrices des bonnes pratiques cliniques (BPC) et de la Conférence internationale sur l'harmonisation (ICH).
- Solides connaissances thérapeutiques et protocolaires telles que fournies dans la formation en entreprise.
- Compétences informatiques, y compris la maîtrise de Microsoft Word, Excel et PowerPoint et l'utilisation d'un ordinateur portable, d'un iPhone et d'un iPad (le cas échéant).
- Compétences en communication écrite et verbale, y compris une bonne maîtrise de la langue anglaise.
Solides compétences en organisation et résolution de problèmes.
- Compétences de gestion efficace du temps et des ressources financières.
- Capacité à établir et entretenir des relations de travail efficaces avec les collègues, les responsables et les clients.
**JOB OVERVIEW**
_Job Profile Summary_
Perform monitoring and site management work for a variety of protocols, site and therapeutic areas. Must be bi-lingual in French and English and locate
**Responsibilities**
_Essential Functions_
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Act as a mentor for clinical staff including conducting co-monitoring and training visits.
Collaborate and liaise with study team members for project execution support as appropriate.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
**MINIMUM REQUIRED EDUCATION AND EXPERIENCE**
**Experience**
Typically requires 2 - 3 years of prior relevant experience.
**Knowledge**
Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.
**Education**
Bachelor's Degree
Degree in scientific discipline or health care preferred.
**Additional Work Experience**
Requires at least 3 years of year of on-site monitoring experience.
Equivalent combination of education, training and experience may be accepted in lieu of degree.
**Skills and Abilities**
In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Strong therapeutic and protocol knowledge as provided in company training.
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
Written and verbal communication skills including good command of English language.
Organizational and problem-solving skills.
Effective time and financial management skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé. IQVIA se consacre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus, visitez est fière d'être un employeur souscrivant au principe de l'égalité d'accès à l'emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l'orientation sexuelle, l'identité de genre, l'origine nationale, le handicap, l'âge, l'état matrimonial ou tout autre statut protégé par la loi applicable. Des mesures d'adaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui nécessite une mesure d'adaptation, nous vous encourageons à contacter notre équipe d'acquisition de talents au , afin qu'IQVIA puisse soutenir votre participation au processus de recrutement.
Veuillez noter qu'il est possible que nous utilisions l'intelligence artificielle (IA) dans le traitement de votre candidature. Cependant, nous utilisons l'IA uniquement pour aider notre équipe de recrutement à sélectionner ou à évaluer les candidatures, et non pas pour remplacer la prise des décisions par les membres de notre équipe.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, or any other status protected by applicable law. Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request. If you have a disability that requires an accommodation, we encourage you to contact our Talent Acquisition Team at: , so that IQVIA can support your participation in the recruitment process.
Please note that we may use artificial intelligence (AI) in the processing of your application. However, we only use AI to assist our recruitment team with the screening or assessment of candidacies, and not as a substitute for human decision-making.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
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