Designation: Clinical Research Coordinator (CRC)

Location: Gurugram (Medanta)

Reporting To: Principal Investigator / Clinical Research Manager

About The Role

We are looking for a detail-oriented and proactive Clinical Research Coordinator (CRC) to support the successful execution of clinical trials while ensuring compliance with regulatory requirements, study protocols, and Good Clinical Practice (GCP) guidelines. The ideal candidate will coordinate study activities, maintain accurate documentation, collaborate with investigators and sponsors, and ensure the highest standards of participant safety and data integrity throughout the clinical research process.

Key Responsibilities

Coordinate and conduct clinical trials in compliance with ICH-GCP guidelines, approved study protocols, SOPs, and applicable regulatory requirements.
Support study start-up activities, including site preparation, participant recruitment, screening, enrolment, follow-up, and retention.
Maintain complete and accurate study documentation, including source documents, Case Report Forms (CRFs), study logs,



Site Master File (SMF), and Investigator Site File (ISF).
Manage Investigational Product (IP) accountability, including receipt, storage, dispensing, reconciliation, shipment, and documentation.
Coordinate submissions, approvals, amendments, and ongoing correspondence with the Institutional Ethics Committee (IEC).
Liaise effectively with Principal Investigators, sponsors, Clinical Research Associates (CRAs), Project Managers, and other stakeholders to ensure smooth study execution.
Support site monitoring visits, sponsor audits, and regulatory inspections by ensuring documentation readiness and compliance.
Report protocol deviations, adverse events (AEs), reliable adverse events (SAEs), and safety information in accordance with study protocols and regulatory guidelines.
Ensure participant confidentiality, informed consent compliance, and timely completion of study documentation and close-out

📌 Clinical Research Coordinator (Gurugram)
🏢 Sova Health
📍 Gurugram