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)
🏢 Sarvodaya Hospital
📍 Faridabad