7 Oncology jobs in Toronto

Nurse Practitioner - Oncology

Brampton, Ontario William Osler Health System

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Job Description

Job Description

Job Description

Company Description

One of Canada's Best Diversity Employers and Greater Toronto's Top Employers for many consecutive years, William Osler Health System (Osler) provides a safe and supportive health care network to grow your career. Osler is nationally recognized for its commitment to patient safety and is Accredited with Exemplary Standing, the highest rating a Canadian hospital can receive. As a major Ontario hospital system, and home to some of the biggest specialty and emergency departments in the country, Osler serves the 1.3 million residents of Brampton, Etobicoke and surrounding communities. We are proud to offer you incredible exposure to best-in-class health care delivery and challenging hands-on opportunities to stay at the top of your game.

A hospital system built for and by the community, we continue to expand our services to meet the needs of a growing population, creating opportunities for increased hands-on skills development, cross-department training and promotional opportunities. Guided by our accomplished senior leadership team, together we are driving our vision of world-class health care inspired by our people and communities.

At Osler, we invest in careers that go beyond where health care professionals like you can achieve their goals and find deep personal and professional fulfillment. Join our team today!

Job Description

  • In consultation/collaboration with the Oncology Program Medical Director and patient care team, the Nurse Practitioner engages in direct clinical practice by:
  • Assessing patient needs
  • Diagnosing and prescribing within scope of practice and approved medical directive protocols
  • Monitoring patient progress, documenting and re-evaluating the patient’s plan of care
  • Identifies clinical practice issues and demonstrates a high level of autonomy and expert skill to formulate clinical decisions and appropriately manage acute/chronic illness, promotes wellness and the educational needs for the acute oncology patient populations in the Oncology Inpatient Unit and Urgent Clinic
  • Engages in  in-service activities and clinical teaching for the oncology patient care team where necessary
  • Leads the development and implementation of corporate wide protocols related to the oncology patient
  • Engages in evidence based practice through research
  • Acts as consultant for the organization internally and externally to advise on systems related to the oncology population
Qualifications

  • Master’s degree in Nursing
  • Acute Care Nurse Practitioner Certificate required
  • Current registration with the College of Nurses
  • Minimum 2 years recent nursing experience in Oncology care
  • Minimum 2 years ACNP experience in the Oncology field
  • Excellent decision making, critical thinking and problem solving skills
  • Excellent negotiation and conflict resolution skills
  • Ability to lead and motivate teams
  • Effective verbal and written communication skills
  • Knowledge of computerized data management and statistical analysis
  • Excellent attendance, punctuality and work record


Additional Information

Hours: Hours: Currently Days, 8 hours including weekends and statutory holidays (subject to change in accordance with operational requirements)

Salary:
Minimum: $62.16 per hour
Maximum: $77.42 per hour

Internal application deadline: (August 26, 2025)

#LI-SC1

Osler values inclusivity and diversity in the workplace. We welcome and encourage applicants from diverse backgrounds. We are committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act. If you require an accommodation at any stage of the recruitment process, please notify Human Resources at

While we thank all applicants, only those selected for an interview will be contacted. Any information obtained during the course of recruitment will be used for employment recruitment purposes only, and not for any other purpose.

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Integrated Clinical Specialist: Palliative Care and Oncology

New
Toronto, Ontario CarePartners

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full-time

Overview

The Integrated Clinical Specialist in Palliative Care and Oncology was established to lead and advance integrated palliative practice across the province. We are seeking a highly skilled, dedicated, and self-motivated individual to support the delivery of high-quality, evidence-based care. As a key member of our Clinical Nursing Excellence team, this position will focus on providing expert care, guidance, and leadership in both palliative care and oncology. The Clinical Specialist will play a pivotal role in shaping interprofessional best practices across the patient care continuum, from birth through end-of-life, supporting both clinical teams and patients.

This role involves close collaboration with internal and external partners to ensure optimal therapeutic outcomes are achieved. Additionally, the Clinical Specialist will serve as a subject matter expert in skill development, working alongside Clinical Practice Leads and the Learning and Development team to foster ongoing professional growth.

This is a Full-Time position that will include planned travel throughout Ontario as required. 

What We Offer

  • Competitive salary, comprehensive health and dental benefits
  • Other employment perks such as Employee Assistance Program, Perkopolis, Rewards Points
  • Flexible work from home arrangements supporting employee work life balance
  • Inspiring leadership and opportunities for professional growth
  • Supportive & dedicated Safety Health & Wellness team & Pandemic Response team
  • Interprofessional collaboration with our Professional Practice Research & Education Team
  • What The Role Involves

    Advance Standards of Care and Professional Practice Palliative and Oncology Care

  • Champions a culture that is committed to and passionate about patient-centered, high-quality and integrated care and the identification of transformative opportunities in enabling point-of-care excellence in every patient and caregiver interaction.
  • Promotes and maintains the application of standards of care, best practice and/or core competencies into the development of processes and policies supporting palliative care and oncology practice in home and community care.
  • Leads the design, implementation and evaluation of the palliative care and oncology program at local branches that align with current standards, evidence-based practice, organizational needs and external customer requirements.
  • Collaborates with interprofessional patient care teams, operations and quality and professional practice leadership supporting the implementation of local, regional and provincial strategies that will advance excellence in clinical outcomes from a population health lens.
  • Implements evidenced based care using an integrated care delivery approach including understanding and elevating the roles of ALL health care professionals (e.g., Personal Support, Therapies and Nursing).
  • Maintains clinical competency in palliative care and oncology.
  • Utilizes instructional design concepts and approach to develop, deliver and coordinate palliative care and oncology care education.
  • Incorporates adult education principles into palliative care and oncology education programs.
  • Develop and implement coaching and mentoring programs to ensure the delivery of the best practices.
  • Provides palliative care and oncology expertise to diverse populations.
  • Facilitates and champions innovative practices, approaches and programming in alignment with CarePartners research initiatives.
  • Participates in the development, maintains and monitors quality practice indicators to ensure ongoing practice fidelity.
  • Supports CarePartners’ strategic priorities relevant to professional practice and ensures leadership is informed of emerging trends in technology, health care, and adult education pertaining to palliative care and oncology.
  • Participates in an on-call rotation for remote support with members of the clinical practice specialist team.
  • Provide high-quality clinical palliative care and oncology consultation and professional practice to internal and external stakeholders such as the local and provincial Patient Care and Operations and Professional Practice leadership, acute care, Ministry of Health e.g., Ontario Health at Home and Ontario Health Teams.
  • Collaborates with the local CarePartners branches to identify issues and trends regarding practice gaps and develops proposal, in collaboration with leadership, to mitigate activities and ensure alignment with high-quality patient-centered practice and programming expectations.
  • Provide strategic advice on palliative care and oncology practice and programming issues and themes.
  • Build Capability and Education

  • Provide consultancy service and support to leadership and frontline staff for the promotion of practice and programming excellence, in line with CarePartners internal and regulatory standards.
  • Supports the consistency of palliative care and oncology practices across the branches.
  • Works closely with Patient Care and Operations leadership and collaborates on clinical orientation, role developments and developments of palliative care and oncology clinical competencies.
  • Acts as a palliative care and oncology resource to facilitate the full scope of practice for team members.
  • Champions the use of digital learning platforms and identifies infrastructure necessary to enable nimble and responsive learning for frontline team members.
  • Supports local site-specific training and coaching initiatives that are informed by key performance indicators, such as patient experience, outcomes measures and risk events.
  • Assists in the development of communication with evidence-based clinical and research content, e.g. QPP emails, company newsletters.
  • Strong proficiency in designing and delivering education and comfort in presenting to large audiences both virtually and in-person.
  • Research and Policy

  • Identify and participate in palliative care and oncology research opportunities as appropriate.
  • Provides evidence-based clinical input into the development, maintenance and implementation of clinical and research policies for nursing, therapy and personal support services.
  • Participates in attending palliative care related conference(s), abstract writing, and speaking at conferences.
  • Special Projects

  • Brings leadership from a professional practice lens to strategic priority projects and programming, as required.
  • Leads and participates in internal project teams and committees as assigned.
  • Other duties, as assigned.
  • What You Bring

  • Registered with the College of Nurses with expertise in palliative and oncology care
  • Master’s Degree in Nursing or working towards is preferred.
  • More than 5 years of healthcare-related experience in leading clinical practice in home and community care is an asset.
  • Knowledge of the OPCN Health Service Delivery Frameworks (Adult Community and Pediatrics (pending)).
  • Knowledge of current Palliative Care Competency Framework (National and Ontario).
  • Knowledge of the CHPCA Model to Guide Hospice Palliative Care.
  • Knowledge of the Gold Standard Framework and Early Identification Tools.
  • Nursing specializing in Palliative Care and Oncology is required or working towards within 6 to 18 months of starting the position.CAPCE certified – within 8 monthsLEAP (Core or Home Care and Pediatrics) certified – within 6 monthsAdvanced Pain Assessment and Management Course – within 8 monthsSerious Illness Conversation Training – within 12 monthsCNA Certification – within 18 monthsFoundations in Oncology – within 12 months (DeSouza Learning Institute)Chemotherapy and Biotherapy Administration certification - within 18 months (DeSouza Learning Institute)
  • LEAP Facilitator would be considered an asset.
  • Expertise in vascular access care and maintenance, including administration.
  • Experience working with ambulatory infusion pumps (i.e. CADD, Saphire, Elastomeric).
  • Knowledge of adult learning principles.
  • Valid driver's license, own vehicle and appropriate insurance
  • CarePartners In Your Community

    In addition to providing home-based health care, CarePartners also serves the community through clinics, transitional care units, and provides relief in retirement homes and shared care settings. Through our Community Nursing Services outreach program, we’ve been organizing staff-led medical care and clinics in countries with poor access to health care since 2009.

    Accessibility

    CarePartners welcomes and encourages applicants from people with disabilities. Candidates can request accommodations at any time in the hiring process.

    This advertiser has chosen not to accept applicants from your region.

    Senior Clinical Research Associate - Oncology/Cross TA - (Toronto / Field Based)

    Toronto, Ontario ICON Clinical Research

    Posted 27 days ago

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    Job Description

    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.
    This advertiser has chosen not to accept applicants from your region.

    Registered Practical Nurse - Medicine Oncology

    Brampton, Ontario William Osler Health System

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    Job Description

    Job Description

    Company Description

    One of Canada's Best Diversity Employers and Greater Toronto's Top Employers for many consecutive years, William Osler Health System (Osler) provides a safe and supportive health care network to grow your career. Osler is nationally recognized for its commitment to patient safety and is Accredited with Exemplary Standing, the highest rating a Canadian hospital can receive. As a major Ontario hospital system, and home to some of the biggest specialty and emergency departments in the country, Osler serves the 1.3 million residents of Brampton, Etobicoke and surrounding communities. We are proud to offer you incredible exposure to best-in-class health care delivery and challenging hands-on opportunities to stay at the top of your game.

    A hospital system built for and by the community, we continue to expand our services to meet the needs of a growing population, creating opportunities for increased hands-on skills development, cross-department training and promotional opportunities. Guided by our accomplished senior leadership team, together we are driving our vision of world-class health care inspired by our people and communities.

    At Osler, we invest in careers that go beyond where health care professionals like you can achieve their goals and find deep personal and professional fulfillment. Join our team today!

    Job Description

    The Registered Practical Nurse (RPN) is a regulated health care professional who is accountable and responsible for providing quality patient focused nursing care to patients who are identified as less complex, demonstrate more predictable outcomes and are at lower risk for negative outcomes in the Oncology and Palliative Department. As part of the inter-professional health care team, the RPN will practice according to the nursing practice expectations set by Osler, the regulatory practice standards of the College of Nurses and the legislative requirements set by the Regulated Health Professions Act.

    Accountabilities:

    • Safe nursing practice in all aspects of the nursing process: assessment, planning, implementation and evaluation of patient care
    • Professional, patient-centred care to ensure patient safety and physiological and psychological well-being
    • Providing care in a compassionate and caring manner within a diverse cultural environment
    • Practicing according to the infection control and prevention measures
    • Responding to emergency situations by recognizing changes in patient's health status and consulting appropriately when necessary using

    This advertiser has chosen not to accept applicants from your region.

    Attach de recherche clinique II, Oncologie /Clinical Research Associate II, Oncology

    Toronto, Ontario IQVIA

    Posted 6 days ago

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    Job Description

    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
    This advertiser has chosen not to accept applicants from your region.

    Attach de recherche clinique II, Oncologie /Clinical Research Associate II, Oncology - IQVIA Biotech

    Mississauga, Ontario IQVIA

    Posted 6 days ago

    Job Viewed

    Tap Again To Close

    Job Description

    **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
    This advertiser has chosen not to accept applicants from your region.

    Attach de recherche clinique II, Oncologie /Clinical Research Associate II, Oncology - IQVIA Biotech

    Toronto, Ontario IQVIA

    Posted 6 days ago

    Job Viewed

    Tap Again To Close

    Job Description

    **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
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