Job Summary

The Clinical Trials is responsible for coordinating and managing clinical research studies in compliance with protocol requirements, ICH-GCP guidelines, regulatory authorities, and hospital policies. The role ensures smooth execution of clinical trials while maintaining participant safety and data integrity.

Key Responsibilities

- Coordinate and manage clinical trial activities from initiation to completion.
- Screen, recruit, and schedule study participants as per protocol.
- Obtain informed consent and ensure ethical conduct of studies.
- Coordinate with Principal Investigators, sponsors, CROs, and hospital departments.
- Maintain study documentation, source documents, and regulatory files.
- Collect, record, and manage clinical trial data accurately.
- Report adverse events and protocol deviations as per regulatory requirements.
- Ensure compliance with ICH-GCP, ethics committee, and applicable regulatory guidelines.
- Prepare for sponsor, regulatory, and internal audits.
- Maintain confidentiality of patient and study information.

Qualifications

- Pharm.D, B.Sc./M.Sc. Life Sciences, Nursing, or equivalent.
- Certification in Clinical Research or GCP is preferred.

📌 Clinical Trails Associate (Hyderabad)
🏢 Sai Sindhu Foundation
📍 Hyderabad