Key Responsibilities
Coordinate and manage clinical trials as per approved study protocols.
Screen and recruit eligible study participants.
Explain study procedures and assist the Principal Investigator in obtaining informed consent.
Schedule study visits and ensure protocol compliance.
Collect, record, and maintain accurate clinical research data.
Maintain source documents, Case Report Forms (CRFs), and Electronic Data Capture (EDC) systems.
Ensure compliance with ICH-GCP, NDCTR, CDSCO, and institutional SOPs.
Prepare and maintain regulatory documents, Investigator Site Files (ISF), and Trial Master Files (TMF).
Coordinate monitoring visits, audits, and inspections.
Report adverse events (AEs), responsible adverse events (SAEs), and protocol deviations to the PI and Ethics Committee.
Coordinate with sponsors, Contract Research Organizations (CROs), laboratories, and hospital departments.
Maintain study drug accountability and documentation (where applicable).
Ensure participant confidentiality and data privacy.
Prepare periodic study reports and assist in study close-out activities.

📌 Clinical Research Executive Faridabad (India)
🏢 Sarvodaya Hospital
📍 India