Clinical Research Coordinator 2 (SRI)-Biological Sciences- Regular Full-time 2025
Sunnybrook Health Sciences Centre
- Toronto, ON
- Permanent
- Full-time
- Function as part of a interdisciplinary, patient-focused team of professionals to ensure smooth and efficient facilitation of clinical trial activities
- Lead the day-to-day activities of a clinical trial including pre-screening/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
- Support the development and execution of high level strategic initiatives within the Nephrology research program
- Minimum 5 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.)
- Advanced 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 to take lead on assigned projects and as part of a team