Responsibilities
- Completion of monitoring reports and follow-up letters, which includes providing summaries.
- Conduction of qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol
- Communication with the medical site staff
- Ensure good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements
- Regulatory document review
- Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
- Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement
- Findings, deviations, deficiencies, and recommended actions to secure compliance
Qualifications
- Experience as a Clinical Research Associate;
- Approximately 60-80% non-local, national travel is required;
- Must have a minimum of a bachelor’s degree in a health or science related field;
- Proficient knowledge of Microsoft® Office;
- Fluency in English and French;
- Outstanding communication skills; and
- Must be detail-oriented and efficient in time management.