Clinical Research Associate
profoundmedical · Mississauga
Job description
About the role
Our mission at profoundmedical is to transform the standard of care by enabling precise tissue ablation using real‑time MR imaging and thermal ultrasound. As a Clinical Research Associate you will support the execution of clinical trials from start‑up through close‑out, ensuring high‑quality data and compliance.
Key responsibilities
- Manage site activities including site initiation visits (SIV), interim monitoring visits (IMV) and close‑out visits.
- Maintain the Trial Master File (TMF) and ensure all documentation is inspection‑ready.
- Review site contracts, budgets and ethics board submissions.
- Perform source data review/verification (SDR/SDV) through on‑site, remote or centralized monitoring.
- Analyze site and study data to identify trends, risks and propose mitigation strategies.
- Build and sustain effective relationships with study personnel and act as a thought partner to improve protocol execution.
- Ensure compliance with Good Clinical Practice (GCP), ethics board approvals and local regulatory requirements.
- Provide training to colleagues or study team members as needed.
Required profile
- Bachelor’s degree in biomedical sciences (MSc or equivalent research experience preferred).
- 1‑3 years of experience in clinical research operations.
- SOCRA/CCRP or ACRP certification preferred, or completion of a clinical research graduate certificate.
Required skills
- Source Data Review/Verification (SDR/SDV).
- Trial Master File (TMF) maintenance.
- Good Clinical Practice (GCP) compliance.
- Site management and monitoring.
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Published 1 month ago
Expires 4 hours from now
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profoundmedical
Mississauga
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