Clinical Research Coordinator

5 days ago

Toronto, Canada Sunnybrook Health Sciences Centre Full time

Sunnybrook Research Institute (SRI) is a $100M multidisciplinary research community, fully affiliated with the University of Toronto, and servicing a broad spectrum of research programs and platforms. The Centre for Clinical Trial Support (CCTS) is SRI’s coordinating centre in support of investigator-driven clinical research projects and clinical trials, and has recently expanded its mandate to support site level clinical trial activities at Sunnybrook in support of SRI’s strategic plan to enhance patient access to research opportunities.

Summary of Duties (not all encompassing):

- Function as part of a interdisciplinary, patient-focused team of professionals to ensure smooth and efficient facilitation of clinical trial activities
- Manage day-to-day activities of a clinical trial including screening and recruiting eligible participants, obtaining informed consent, collecting and managing study data and ensuring compliance with protocols and regulatory guidelines
- Initiate, manage, and coordinate submissions to Research Ethics Board and contracts for Legal Review
- Communicate with internal hospital departments to complete impact assessments, facilitate departmental research agreements and obtain institutional approvals
- Financial duties relating to clinical trial activities including budget development, invoicing and study-related patient reimbursements
- Establish, maintain and complete all essential documents in Investigator Site File (ISF) ensuring adherence to regulatory requirements
- Coordinate patient follow-up visit schedules as per study protocol and execution of all aspects of study visits including protocol specific assessments such as obtaining patient vitals, electrocardiograms and sample collection/processing
- Report Adverse Events/Serious Adverse Events as per protocol and sponsor requirements
- Liaise with sponsors as required
- Prepare for monitoring visits, audits and inspections
- Provide support to Site Operations Manager in tasks including but not limited to collection/reporting of institutional Key Performance Indicators, establishing clinical trial workflows and tools/templates
- Support implementation of a clinical trial management system

Qualifications/Skills:

- Minimum 3 years of clinical research experience in a hospital setting
- Bachelor’s degree in health-related field required, Master’s degree is an asset
- Recognized certification in clinical research (ACRP or SOCRA) is an asset
- Training and experience or willingness to be trained in Phlebotomy/Venipuncture practice required
- Demonstrated knowledge of research regulations and guidelines (ICH/GCP, Health Canada, Tri-Council Policy, Declaration of Helsinki, etc.)
- Proficiency in computer skills (Microsoft Office: Word, Excel, PowerPoint, Adobe) - Experience with Clinical Trial Management Systems and Electronic Data Capture systems an asset
- Strong oral and written communication skills
- A “can do” attitude: Flexibility to work in a complex environment with ability to multitask and prioritize to meet deadlines
- Demonstrates initiative and the ability to work effectively both independently and as part of a team

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