Job Description

Job Responsibility:

? Lead and manage the day-to-day conduct of clinical trials at the site.

? Ensure adherence to study protocols, ICH-GCP guidelines, and regulatory requirements.

? Serve as the primary point of contact between the site and the sponsor/CRO.

? Prepare, submit, and maintain regulatory documents (e.g., EC/IRB submissions, clinical trial agreements).

? Ensure informed consent forms are accurate and up to date.

? Oversee subject recruitment, screening, enrollment, and follow-up.

? Ensure Proper informed consent process is conducted.

? Monitor and manage subject safety, adverse events (AEs/SAEs), and protocol compliance ? Ensure accurate and timely data entry into electronic data capture (EDC) systems.

? Resolve data queries and discrepancies.

? Maintain complete and accurate source documentation.

? Mentor and train junior coordinators or clinical staff.

? Delegate tasks effectively while maintaining overall oversight.

? Conduct internal study meetings and updates.

? Collaborate closely with investigators, sponsors, monitors, and site staff.

? Report trial progress, recruitment status, and site metrics regularly.

? Coordinate logistics for study visits, sample shipments, and drug/device accountability

Job Type: Full-time

Pay: ₹15,000.00 - ₹18,000.00 per month

Benefits:

Paid sick time Paid time off
Application Question(s):

Have you done B.pharm or M.pharm?
Education:

Bachelor's (Preferred)
Location:

Nikol, Ahmedabad, Gujarat (Required)
Work Location: In person