Senior Clinical Research Associate managing oncology trial sites for Worldwide Clinical Trials, a global contract research organization. Overseeing study start - up, site maintenance, safety reporting, and closeout across Canada.
About the role
- Clinical Research Associate executing clinical trials for Profound Medical’s precision MR-guided ultrasound cancer treatments. Managing sites, monitoring data, maintaining TMF compliance, and supporting trial closeout.
Responsibilities
- Analyze, question, and improve how clinical trial work is done while meeting business objectives through efficient, quality trial execution from startup to closeout
- Execute core clinical operations activities, including site management, SIV, IMV, closeout visits, and Trial Master File (TMF) maintenance
- Participate in reviews of site contracts, budgets, and ethics board submissions
- Build and maintain effective relationships with study personnel
- Investigate issues independently, identify root causes, and propose solutions
- Ensure study data are accurate, complete, and verifiable through SDR/SDV and on-site, remote, or centralized monitoring
- Analyze site and study data to identify inconsistencies, trends, and potential risks, and develop mitigation strategies
- Engage sites to improve protocol understanding and execution
- Communicate findings, issues, and recommendations clearly and concisely
- Maintain clear, logical, compliant, and inspection-ready TMF documentation
- Improve processes, clarity, and efficiency
- Ensure study conduct, TMF, and adverse event reporting comply with ethics board approval, GCP guidelines, and applicable regulatory requirements
- Conduct training for colleagues or the study team as requested
- Perform other duties as required by the company
Requirements
- Bachelor’s degree in biomedical sciences required
- MSc (thesis-based preferred) or equivalent research experience
- SOCRA/CCRP or ACRP certification preferable, or completion of a clinical research graduate certificate
- Minimum of 1–3 years of experience
- Strong written communication skills
- Ability to think critically beyond following process
- High initiative, ownership, and work ethic
- Ability to structure and present information clearly
- Experience administering and conducting clinical trials from startup to closeout
- Proficiency in GCP guidelines, ethics board policies, applicable regulatory requirements, and related processes
- Proven ability to establish and maintain relationships with study site personnel
- Proficiency in data management and quality management
- Knowledge of adverse event reporting procedures and applicable regulatory requirements
- Experience conducting site initiation, monitoring, and close-out visits, both onsite and remotely
- Ability to manage multiple tasks, track project milestones, and ensure timely delivery
- Ability to work independently and collaboratively
- Ability to travel up to 60% of the time for site visits, monitoring visits, SIVs, and investigator interactions within Canada and the United States
Benefits
- Participation in the company’s benefits programs may be available
- Group RRSP
- Medical benefits paid by the employer
- Workplace accommodation support for candidates with disabilities
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