20 Medical Researchers jobs in Toronto

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Role:**
CRA Level I/II
**Location:**
CAN, Toronto- Remote
**Experience Requirements:**
Previous Clinical Monitoring; on site or Remote
**(REQUIRED)**
Travel- up to 80%
**(REQUIRED)**
At Thermo Fisher Scientific, youu2019ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on u2013 now and in the future.
**Location/Division Specific Information**
Our global Clinical Operations colleagues within our PPDu00ae clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
**Discover Impactful Work:**
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
**A day in the Life:**
Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
Assess investigational product through physical inventory and records review.
Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Role:** CRA Level I/II
**Location:** CAN, Toronto- Remote
**Experience Requirements:**
+ Previous Clinical Monitoring; on site or Remote **(REQUIRED)**
+ Travel- up to 80% **(REQUIRED)**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
**Discover Impactful Work:**
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
**A day in the Life:**
+ Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
+ Assess investigational product through physical inventory and records review.
+ Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
+ May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator

As a CRA you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.
En tant qu'ARC (Associé(e) de recherche clinique), vous rejoindrez la plus grande et la plus complète organisation de recherche clinique au monde, propulsée par l'intelligence en santé.
**What you will be doing:**
+ Conduct clinical trial site visits including evaluation, initiation, monitoring and close out
+ Oversee and report on the conduct of clinical trials at a site level including and on-line site visit reports and updates to electronic management systems
+ Proactive site management including:
+ Building and maintaining solid and professional relationships with site staff
+ Facilitating subject enrolment incorporating recruitment strategies and action plans at site level
+ Maintaining site audit/inspection readiness
+ Ensuring appropriate safety reporting and use of on-line safety reporting/reviewing systems such as Intralinks
+ Verification of electronic case report form data against written and electronic source documentation as per study schema/monitoring plan
+ Responding to site queries and escalating issues in accordance with processes and timelines
+ Conducting IP accountability and reconciliation
+ Facilitating implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting)
+ Maintenance of site study supplies
Operational Excellence:
+ Contribute to sponsor goals
+ Promote operational and scientific excellence
+ Identify opportunities and best practices with local/regional partners that will contribute to the overall operational effectiveness.
**Gestion des sites d'essais cliniques**
+ Effectuer des visites de sites d'essais cliniques : incluant l'évaluation, l'initiation, la surveillance et la clôture.
+ Superviser et rendre compte de la conduite des essais cliniques : au niveau du site, y compris les rapports de visites en ligne et les mises à jour des systèmes de gestion électroniques.
+ Gestion proactive des sites, incluant :
+ Établir et maintenir des relations solides et professionnelles avec le personnel du site.
+ Faciliter l'enrôlement des sujets en intégrant des stratégies de recrutement et des plans d'action au niveau du site.
+ Maintenir la préparation à l'audit/inspection du site.
+ Assurer la déclaration appropriée des événements indésirables et l'utilisation des systèmes de déclaration/évaluation en ligne tels qu'Intralinks.
+ Vérifier les données des formulaires électroniques de rapport de cas (eCRF) par rapport à la documentation source écrite et électronique, conformément au schéma de l'étude/plan de surveillance.
+ Répondre aux questions du site et escalader les problèmes conformément aux processus et délais.
+ Effectuer la responsabilité et la réconciliation des produits de l'essai (IP).
+ Faciliter la mise en œuvre de nouvelles technologies et systèmes sur les sites cliniques (Collecte de données électronique, déclaration eSAE).
+ Maintenir les fournitures d'étude du site.
**Excellence opérationnelle**
+ Contribuer aux objectifs du promoteur.
+ Promouvoir l'excellence opérationnelle et scientifique.
+ Identifier les opportunités et les meilleures pratiques avec les partenaires locaux/régionaux qui contribueront à l'efficacité opérationnelle globale.
**You are:**
+ BA/BS/BSc in the sciences or nursing equivalent
+ A trained CRA with on-site monitoring experience
+ Comprehensive knowledge and understanding of ICH-GCP
+ Fluent oral (face to face and telephone) and written English language skills
+ Able and willing to travel up to 60% of the time or as per local requirements
+ Possession of a full driver's license
+ Able and willing to work from a designated and appropriate home office as per local requirements
+ Willing to attend and contribute to team meetings including mandatory training (remote/off-site)
+ Competent computer skills including working knowledge of common software packages
+ Working knowledge of trial management databases and on-line systems
+ Able to attend a 1 week face to face in-house training course as part of on-boarding training
+ Able and willing to work on several protocols/therapy areas
+ Experience in phase II and phase III trials (preferred)
+ Working knowledge of Electronic Data Capture (preferred)
Experience/working knowledge of the oncology disease area (preferred)
+ Experience of Centralized/Risk Based/Targeted monitoring (preferred)
+ Experience of working within a metric based environment (preferred)
+ Diplôme universitaire en sciences de la vie ou en soins infirmiers (équivalent d'un BA/BS/BSc).
+ Certification d'infirmier(ère) autorisé(e) (RN) ou qualification académique/ professionnelle équivalente.
+ Expérience préalable en surveillance clinique sur site, généralement de 1 à 2 ans.
+ Connaissance approfondie des Bonnes Pratiques Cliniques (BPC/ICH-GCP) et des réglementations locales.
+ Compétences en communication orale et écrite en anglais, avec une maîtrise des termes médicaux.

**Fonction :** Coordonnateur de recherche clinique
**Configuration de travail :** Travailler au centre
**Horaire** **:** À déterminer
**Heures :** 24 heures par semaine.
**Responsabilités :**
+ **Phlébotomie** est requise, et une expérience pédiatrique est également nécessaire. De plus, la sensibilisation de la communauté fera partie du rôle.
+ Effectuer une variété de procédures cliniques complexes sur des sujets, y compris, mais sans s'y limiter, **ECG, prélèvement d'échantillons incluant la spirométrie et les signes vitaux.**
+ Coordonner les études de recherche clinique menées par un investigateur principal superviseur.
+ Mettre à jour et maintenir les compétences, la formation et les connaissances des meilleures pratiques infirmières actuelles et des sujets liés à la recherche clinique.
+ Préserver le bien-être des sujets et assurer et maintenir des normes élevées :
+ Maintenir un environnement sûr conformément aux politiques de santé et de sécurité.
+ Agir en tant que défenseur bénévole.
+ Répondre aux préoccupations des bénévoles et des visiteurs de manière proactive et prenez les mesures correctives nécessaires.
+ Aider le personnel, inscrit ou non, dans les pratiques de coordination clinique et la prestation de soins aux bénévoles.
+ Signaler tout écart par rapport à la pratique normale au personnel supérieur.
**Soutenir l'étude menée par :**
+ Examen du protocole d'étude, du cahier d'observation (CRF), d'autres documents d'étude et des systèmes de saisie électronique des données.
+ Participer aux réunions de projet avec l'équipe de projet selon les besoins.
+ Réaliser la mise en place clinique et la préparation de l'étude, y compris l'étiquetage des tubes et conteneurs de prélèvement d'échantillons, la mise en place de l'équipement et des documents.
+ Planification des activités logistiques pour les procédures conformément au protocole.
+ Générer des instructions pour les bénévoles.
+ Identifier et obtenir les fournitures et l'équipement nécessaires.
+ Préparer et diffuser des supports de formation, de documents et de dossiers spécifiques à l'étude.
+ Dépannage des problèmes d'étude.
+ Participer à des réunions pour garantir que les tâches quotidiennes assignées aux membres de l'équipe sont exécutées selon les normes attendues.
+ Aider à la vérification de la qualité des données et à la résolution des requêtes pour garantir que les données collectées sur les volontaires de l'étude respectent le protocole de l'étude et assurer le contrôle de la qualité pour l'exactitude et l'exhaustivité du contenu.
+ Recrutement et sélection des volontaires à inclure dans l'étude sur la base de critères prédéterminés.
+ Orienter les bénévoles vers l'étude et le centre, y compris l'objectif de l'étude, les procédures et les questions pratiques telles que les délais des visites.
+ Responsable de l'administration et de la garde correctes du médicament à l'étude conformément aux procédures opérationnelles standard du centre.
+ Collecter, enregistrer et signaler les données et les résultats cliniques de manière appropriée dans les cahiers d'observation (CRF). Collaborer étroitement avec l'investigateur de l'étude, informer sur les événements indésirables pertinents et les événements indésirables graves conformément aux procédures décrites dans le protocole.
+ Coopérer avec le moniteur d'étude et réserver suffisamment de temps pour les questions pendant le suivi.
+ Suivre les directives BPC CIH concernant toutes les activités d'étude et de patient.
**Qualifications :**
+ Diplôme d'études secondaires et 3 ans d'expérience professionnelle pertinente en recherche clinique ou baccalauréat préféré avec 2 ans d'expérience professionnelle pertinente.
+ Au moins 1 an d'expérience de travail dans un contexte de recherche clinique est préférable.
+ Certifications et licences applicables requises par l'entreprise, le pays, l'État et/ou d'autres organismes de réglementation.
+ Connaissance pratique des essais cliniques.
+ Connaissance pratique des principes des bonnes pratiques cliniques (BPC).
+ Connaissance approfondie du protocole et des procédures opérationnelles spécifiques à l'étude, des formulaires de consentement et des calendriers d'étude.
+ Compétence dans la réalisation des procédures cliniques requises.
+ Connaissance pratique de la terminologie médicale.
+ Capacité à prêter une attention particulière aux détails.
+ Capacité à établir et à maintenir des relations de travail efficaces avec les collègues, les responsables, les patients, les médecins et les clients.
**Job Title:** Clinical Research Coordinator
**Work Set-Up:** Working On-site
**Schedule** : Tuesdays, Thursdays, and Saturdays, with the possibility of one additional weekday. Total hours: 24 hours per week.
**Responsibilities:**
+ **Phlebotomy** is required, and pediatric experience is also needed. Additionally, community outreach will be part of the role.
+ Perform a variety of complex clinical procedures on subjects including but not limited to **ECG, sample collection including spirometry, and vital signs.**
+ Coordinate clinical research studies conducted by a supervising principal investigator.
+ Update and maintain skills, training, and knowledge of current best nursing practices and topics related to clinical research.
+ Safeguard the well-being of the subjects and ensure and maintain high standards:
+ Maintain a safe environment in accordance with Health and Safety policies.
+ Act as a volunteer advocate.
+ Address volunteer and visitor concerns proactively and take remedial action as required.
+ Assist staff, both registered and unregistered, in clinical coordinator practices and the delivery of care to the volunteer.
+ Report any deviation from normal practice to senior staff.
**Support Study Conduct By:**
+ Reviewing the study protocol, case report form (CRF), other study documents, and electronic data capture systems.
+ Participating in project meetings with the project team as needed.
+ Performing clinical set-up and preparation for the study including labeling specimen collection tubes and containers, setting up equipment and documents.
+ Planning logistical activity for procedures as per protocol.
+ Generating volunteer instructions.
+ Identifying and obtaining required supplies and equipment.
+ Preparing and delivering study-specific training materials, documents, and records.
+ Troubleshooting study issues.
+ Participating in huddles to ensure daily tasks assigned to team members are executed to the expected standards.
+ Assisting with data quality checking and query resolution to ensure that data collected on study volunteers adhere to study protocol and ensuring quality control for content accuracy and completeness.
+ Recruiting and screening volunteers for inclusion in the study based on pre-determined criteria.
+ Orienting volunteers to the study and the site including the purpose of the study, procedures, and practical issues such as timelines for visits.
+ Responsible for the correct administration and custody of study drug according to site standard operating procedures.
+ Collecting, recording, and reporting clinical data and findings appropriately in case report forms (CRFs). Collaborating closely with the study investigator, informing on relevant adverse events and serious adverse events according to procedures outlined in the protocol.
+ Cooperating with the study monitor and reserving sufficient time for questions during monitoring.
+ Following ICH GCP guidelines with regards to all study and patient activities.
**Qualifications:**
+ Equivalent education and experience - High School Diploma and 1 years' relevant work experience in clinical research
+ At least 1 year experience working in a clinical research setting preferred.
+ Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies.
+ Working knowledge of clinical trials.
+ Working knowledge of the principles of Good Clinical Practices (GCP).
+ In-depth knowledge of protocol and study-specific operating procedures, consent forms, and study schedules.
+ Skill in carrying out required clinical procedures.
+ Working knowledge of medical terminology.
+ Ability to pay close attention to detail.
+ Ability to establish and maintain effective working relationships with coworkers, managers, patients, physicians, and clients.
_Please note, this position is not eligible for sponsorship._
#LI-CES and #LI-DNP #LI-HCP #ONSITE
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

As a CRA you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.
En tant qu'ARC (Associé(e) de recherche clinique), vous rejoindrez la plus grande et la plus complète organisation de recherche clinique au monde, propulsée par l'intelligence en santé.
**What You'll Be Doing:**
+ Serve as the primary point of contact between investigational sites and the sponsor
+ Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
+ Ensure site compliance with ICH-GCP, SOPs, and Health Canada regulations
+ Maintain up-to-date documentation in CTMS and eTMF systems
+ Support and track site staff training and maintain compliance records
+ Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
+ Support subject recruitment and retention efforts at the site level
+ Oversee drug accountability and ensure proper storage, return, or destruction
+ Resolve data queries and drive timely, high-quality data entry
+ Document site progress and escalate risks or issues to the clinical team
+ Assist in tracking site budgets and ensuring timely site payments (as applicable)
+ Collaborate with cross-functional partners including CTAs, LTMs, and CTMs
**Ce Que Vous Ferez:**
+ Servir de point de contact principal entre les sites d'études et le promoteur
+ Effectuer tous les types de visites sur site, y compris la sélection, l'initiation, la surveillance de routine et la clôture
+ Assurer la conformité du site aux normes ICH-GCP, aux SOPs et aux règlements de Santé Canada
+ Maintenir la documentation à jour dans les systèmes CTMS et eTMF
+ Soutenir et suivre la formation du personnel du site et tenir les dossiers de conformité à jour
+ Surveiller la sécurité des patients, en assurant un signalement rapide et précis des AE/SAE/PQC
+ Appuyer les efforts de recrutement et de rétention des participants à l'étude au niveau du site
+ Superviser la gestion des médicaments, y compris leur entreposage, leur retour ou leur destruction appropriée
+ Résoudre les requêtes de données et encourager une saisie de données rapide et de haute qualité
+ Documenter l'avancement du site et signaler tout risque ou problème à l'équipe clinique
+ Contribuer au suivi du budget du site et veiller aux paiements rapides (le cas échéant)
+ Collaborer avec les partenaires interfonctionnels, incluant les CTA, LTM et CTM
**You are:**
+ Based in Toronto Canada
+ Eligible to work in Canada without visa sponsorship
+ A clinical research professional with 3+ years of on-site monitoring experience in the pharmaceutical or CRO industry
+ Oncology monitoring experience is required
+ Experienced across multiple therapeutic areas, ideally including Oncology, Hematology, Prostate Cancer, Lung Cancer, and Early Phase/Phase 1.
+ A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN
+ Knowledgeable in Health Canada regulations and working with Research Ethics Boards (REBs)
+ Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
+ A clear communicator, problem-solver, and collaborative team player
+ Willing and able to travel approximately 50% for on-site monitoring visits
**Vous êtes:**
+ Basé(e) dans Toronto canadien
+ Autorisé(e) à travailler au Canada sans parrainage de visa
+ Un(e) professionnel(le) de la recherche clinique avec plus de 3 ans d'expérience en surveillance sur site dans l'industrie pharmaceutique ou auprès d'une CRO
+ Une experience de la surveillance de l'oncologie est requise
+ Expérimenté(e) dans plusieurs aires thérapeutiques, idéalement en oncologie, hématologie, cancer de la prostate, cancer du poumon et en phases précoces / Phase 1
+ Titulaire d'un baccalauréat en sciences de la vie ou d'un diplôme équivalent, ou infirmier(ère) autorisé(e) (IA)
+ Connaissant bien les règlements de Santé Canada et le travail avec les comités d'éthique de la recherche (CER)
+ Maîtrisant les ICH-GCP, les exigences réglementaires locales et les systèmes cliniques comme le CTMS et le eTMF
+ Un(e) communicateur(trice) clair(e), apte à résoudre des problèmes et collaboratif(ve) au sein d'une équipe
+ Prêt(e) et capable de voyager environ 50 % du temps pour des visites de surveillance sur site
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs
+ Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
+ Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

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.
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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.
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