09 Nov
|
Saskatchewan Health Authority
|
Canada
09 Nov
Saskatchewan Health Authority
Canada
Apply clinical research expertise to human-subject studies under PI direction, emphasizing Good Clinical Practice compliance and regulatory documentation. This position supports accurate, effective trial conduct.
The Clinical Research Associate facilitates clinical research under the general direction of a Principal Investigator and Provincial Leader of Clinical Trials. Responsibilities include managing submissions, revisions, amendments, and safety alerts. The work also addresses Canadian Health Products and Food Branch and US Food and Drug Administration requirements.
Key Responsibilities:
- Facilitate clinical research involving human subjects
- Support efficient, accurate, GCP-compliant trial conduct
- Document submissions, revisions, amendments, and safety alerts promptly
- Ensure HPFB and FDA submission requirements are met
Requirements:
- Health Information Management diploma or health-related bachelor degree
- One year clinical research experience involving direct patient care
- Alternatively, three years oncology experience as health information practitioner
- ACRP or SoCRA certification, or obtain within two years
- Advanced human-subject research principles knowledge
Use clinical research, GCP, documentation, and regulatory knowledge to support compliant human-subject trials.
📌 Clinical Research Associate GCP Compliance (Canada)
🏢 Saskatchewan Health Authority
📍 Canada