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CCTS is seeking a highly motivated individual looking to expand their clinical research portfolio to join our site operations team as a Clinical Research Assistant. The successful candidate will be based on-site and work closely with Principal Investigators and interdisciplinary teams to support the activation and coordination of multiple clinical trials across various research programs (location may vary) in addition to supporting CCTS Site Operations Manager and CCTS Co-Directors in the operationalization of initiatives aimed to strengthen clinical research infrastructure at SRI.
Summary Of Duties (not All Encompassing)
- Function as part of an 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
- Support, 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
- 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
- Minimum 2 years of clinical research experience in a hospital setting
- Bachelor’s degree in health-related field 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
- Applies straightforward technical knowledge and skills to perform well-defined, routine and/or repetitive tasks
- 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
