The opportunity
Position Summary: The Clinical Study Monitor oversees the day-to-day execution and monitoring of clinical studies involving in vitro diagnostic (IVD) devices, focusing on companion diagnostics (CDx) developed with pharmaceutical and academic partners. You will ensure studies…
What you'll do
Serve as the primary point of contact for testing sites, ensuring protocol: compliance, subject safety, and data quality align with GCP, FDA, and IVDR requirements.
Execute monitoring activities based on the study-specific plan, including: source data verification (SDV), essential document review, specimen tracking, and resolving sample handling issues.
Drive the operational execution of clinical studies, from start-up and site: qualification through routine monitoring and close-out.
Prepare clear, objective monitoring visit reports, tracking site findings,: protocol deviations, and CAPAs through to resolution.
Take ownership of developing study-related documents, relying on strong: judgment to move work forward even when standard processes are still being built.
Collaborate across Clinical Operations, Regulatory Affairs, and Quality: Assurance to align on study execution and quality expectations.
What they're looking for
- Support IRB/EC submission activities and ensure ongoing ethical compliance.
- Manage study documentation, including preparation, review, filing, and: archiving in the Trial Master File (TMF).
- Support audit readiness by preparing monitoring summaries and participating: in internal audits or regulatory inspections.
- Identify, escalate, and resolve study risks, protocol deviations, and: reportable events (e.g., adverse events) in accordance with regulations.
