Clinical Research Coordinator

Job Description

Company Name :- Medigence Solutions Pvt Ltd Site Location:- Surat Designation: Senior Clinical Research Coordinator (Senior CRC) Experience: 4+ Years Qualification: B. Pharm, M. Pharm, B. Sc or M. Sc 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