Senior Clinical Research Associate – FSP

Job Description

The Senior Clinical Research Associate will: - Manage site activities to ensure adherence to the clinical protocol, monitoring plan, ICH GCP guidelines, local regulations, and sponsor SOPs. - Conduct qualification, initiation, interim, and close-out visits, both on-site and remote. - Collaborate with the Clinical Trial Liaison (CTL) and other sponsor roles to facilitate site activation and deliverables. - Foster productive professional relationships with investigator site staff. - Oversee drug accountability, reconciliation, and destruction, ensuring protocol compliance. - Prepare and maintain the Oversight Monitoring Plan. - Perform Oversight Monitoring Visits at research sites. - Review and report on the progress of study conduct at the investigator site. - Ensure site regulatory files are up-to-date and study documentation is submitted promptly. - Identify and document protocol deviations, escalate non-compliance, and resolve study-related challenges. - Maintain consistent communication with site personnel, study teams, and relevant stakeholders. - Support inspection readiness efforts and guarantee data integrity and protocol deliverables.

Qualifications

The ideal candidate should have: 1. A Bachelor's degree (or equivalent). 2. A minimum of 5 years of related experience as a Senior CRA. 3. Strong analytical and problem-solving capabilities, along with critical thinking skills. 4. In-depth knowledge of the clinical drug development process, ICH GCP guidelines, and relevant regulatory requirements (e.g., FDA, EMA, PMDA). 5. Excellent communication and interpersonal skills for building internal and external relationships. 6. Familiarity with medical terminology and proficiency in IT applications, including Microsoft Office, EDC, CTMS, and data repositories. 7. Proven ability to deliver clear and concise written reports. 8. Effective prioritization and time management skills.

Benefits

- Health insurance - Paid time off - Professional development opportunities