06 Aug
|
The Royal
|
Varennes
06 Aug
The Royal
Varennes
About the ProgramThe REB Coordinator / Clinical Research Facilitator and Contracts Officer plays a key role in ensuring the ethical integrity and regulatory compliance of all clinical research activities conducted at The Royal, while managing the day-to-day review and execution of research contracts. Acting as the primary liaison for the Research Ethics Board (REB) and a trusted advisor to research teams, this role ensures high standards in ethics review, research quality, and regulatory oversight, combining strong organizational skills with deep knowledge of research ethics and clinical research operations.Key ResponsibilitiesManage and coordinate the daily operations of the REB Office in collaboration with the REB Chair and Vice-Chair.Conduct in-depth reviews of research protocols to ensure alignment with TCPS2, ICH-GCP, institutional policies, and regulatory requirements.Provide education, support, and guidance to investigators and research staff on ethical requirements, regulatory updates, and REB submission processes.Oversee REB document management, meeting coordination, protocol review assignments, decision tracking, meeting minutes, and decision letters.Monitor trends in research ethics and implement improvements to REB processes, quality standards, and operational efficiency.Develop and deliver training in clinical research ethics, regulatory compliance, and Positive Clinical Practice (GCP), while supporting protocol development, documentation, and compliance.Participate in the Quality Assurance for Research Excellence (QARE) Program, including audits, monitoring visits, compliance reviews, risk mitigation, and corrective action guidance.Develop tools, templates, and standard operating procedures to support clinical research activities and continuous improvement.Coordinate and collaborate with internal and external stakeholders, including investigators, collaborators, research sponsors, and regulatory partners,
and represent The Royal on committees and external forums related to clinical research and ethics.Review, draft, negotiate, and manage research-related agreements, including sponsored research agreements, clinical trial agreements, data transfer agreements, material transfer agreements, and transfer of funds agreements, while ensuring compliance with institutional policies, sponsor requirements, ethics and privacy legislation, and applicable laws. Track contract amendments, terminations, and extensions, and identify and mitigate legal, financial, and ethical risks.QualificationsDiploma in Clinical Research, Health Sciences, or a related field. Bachelor's or Master’s degree in health administration, Research Ethics, or a related discipline is preferred.Minimum 5–7 years of progressive experience in clinical research ethics, regulatory affairs, or clinical trial coordination.Society of Clinical Research Associates (SOCRA) certification.Knowledge, Skills & AbilitiesDirect experience managing REB processes or serving as a Research Ethics Coordinator is considered an asset.Strong knowledge of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), ICH-GCP, and Health Canada Division 5 Food and Drug Regulations.Knowledge of clinical research conduct related to ethical oversight, regulatory requirements, and good documentation practices.Familiarity with PHIPA, PIPEDA, research privacy standards, and U.S. FDA 21 CFR regulations.Ability to interpret and apply research ethics, regulatory, and institutional requirements in a clinical research environment.Strong knowledge of MS Office,
including managing spreadsheets, creating and reviewing documents and templates, and developing presentations.Strong analytical, critical thinking, and ethical reasoning skills to evaluate research protocols and ensure compliance with ethical standards.Effective project coordination and time management skills, with the ability to manage multiple REB submissions, competing deadlines, and prioritize tasks in a fast-paced environment.High attention to detail with strong documentation and data management capabilities.Excellent verbal and written communication skills, with the ability to educate, advise, and train investigators, staff, students, researchers, and clinicians.Language RequirementsEnglish level A- is mandatory in oral expression, oral comprehension, reading comprehension and written expression. Bilingual (French/English) is preferred.BenefitsAt The Royal, we are committed to supporting your health, well-being, and financial security at every stage of your career through a comprehensive total rewards package that may include:HOOPP, one of Canada's leading defined benefit pension plans, helping you build long-term financial security with a predictable lifetime retirement income and valuable employer contributions.Competitive health and dental benefitsthrough MedavieBlue Cross (MBC), supporting you and your family's health and wellness needs; Life insuranceand disability coveragethrough Manulife, including short-term and long-term disability benefits where applicable, providing added peace of mind; Employee and Family Assistance Program (EFAP) through Telus Health, offering confidential counselling, wellness resources, and support services for you and your eligible family members (excluded casual staff).Together, these benefits reflect our commitment to helping you thrive personally and professionally—today, tomorrow, and throughout your career at The Royal.#J-18808-Ljbffr
📌 Re Board Coordinator At The Royal (Varennes)
🏢 The Royal
📍 Varennes