Clinical Trial Coordinator

About the Role

We are looking for a highly motivated and detail-oriented Clinical Research Coordinator (Fresher) to support the execution of clinical trials in compliance with ICH-GCP guidelines, regulatory requirements, and study protocols. The candidate will assist in coordinating clinical research activities, maintaining documentation, and ensuring subject safety and data integrity.

Key Responsibilities

• Assist in the coordination and management of clinical trials (Phase I–IV studies)
• Ensure compliance with ICH-GCP, FDA, DCGI, and regulatory guidelines
• Support in site initiation, monitoring, and close-out visits
• Maintain and update Trial Master File (TMF) and Investigator Site File (ISF)
• Assist in informed consent process (ICF) documentation
• Coordinate with Principal Investigator (PI), Sub-Investigators, Sponsors, and CROs
• Ensure accurate data entry in Case Report Forms (CRF/eCRF)
• Handle source documentation and query resolution
• Track and report Adverse Events (AE) and Serious Adverse Events (SAE)
• Maintain subject recruitment and retention records
• Schedule patient visits and follow-up appointments
• Support in regulatory submissions and ethics committee documentation

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Microbiology, or related field
• Freshers or candidates with internship in Clinical Research / Clinical Trials
• Knowledge of GCP, Clinical Trial Process, Regulatory Guidelines
• Strong documentation and communication skills
• Basic understanding of Medical Terminology and Pharmacovigilance

Required Skills & Tech Stack

• Clinical Research
• Clinical Trials
• GCP
• ICH Guidelines
• FDA Regulations
• DCGI
• TMF
• ISF
• CRF
• eCRF
• AE/SAE Reporting
• Regulatory Documentation
• Ethics Committee
• Site Management
• Data Management
• Monitoring Support
• Pharmacovigilance
• CRO
• Investigator Coordination
• Source Documentation
• Patient Recruitment