Clinical Trial Associate

Role & responsibilities

. Study Monitoring

• Conduct site initiation, routine monitoring, and close-out visits.
• Ensure adherence to study protocol, GCP guidelines & regulatory requirements.
• Verify informed consent forms and ensure ethical compliance.
• Review and validate source documents, CRFs, and eCRF entries.
• Identify protocol deviations and ensure corrective actions are implemented.

2. Site Management

• Train investigators, coordinators, and site staff on study procedures.
• Maintain oversight of site performance and subject recruitment status.
• Ensure availability of study supplies, trial materials, and drug accountability.
• Build strong relationships with investigators and site teams.

3. Documentation & Compliance

• Maintain Trial Master File (TMF) and site-level documentation.
• Ensure timely reporting of adverse events (AEs) and serious adverse events (SAEs).
• Prepare monitoring reports and follow-up letters.
• Ensure data integrity and compliance with SOPs, ICH-GCP, CDSCO/EMA/FDA requirements.

4. Coordination & Communication

• Work with project managers, data managers, and medical monitors.
• Participate in investigator meetings and internal team meetings.
• Provide feedback and updates on site status and trial progress.