Job Description

Key Responsibilities

1. 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.
Job Type: Full-time

Pay: ?30,000.00 - ?40,000.00 per month

Benefits:

Health insurance Provident Fund
Work Location: In person