Role Overview
Plan, execute, and monitor clinical trials and research projects in accordance with Good Clinical Practice (GCP) guidelines, protocol specifications, and statutory regulatory standards.
Key Responsibilities
- Subject Recruitment & Screening: Identify, recruit, and screen eligible clinical trial candidates based on strict study protocol inclusion and exclusion criteria.
- Data Management & Documentation: Accurately collect, document, process, and maintain Case Report Forms (CRFs), source documents, and essential trial master files (TMF).
- Stakeholder & Ethics Coordination: Liaise between Principal Investigators (PIs), sponsors, Contract Research Organizations (CROs), and Institutional Ethics Committees (IEC) for approvals, progress reports, and notifications.
- GCP Compliance & Audits: Ensure strict adherence to GCP guidelines, ICMR/FDA regulatory requirements, patient safety standards, and informed consent protocols during trial execution.
- Sample Handling & Trial Supplies: Oversee investigational product (IP) accountability, sample storage, biological specimen shipping, and clinical trial material logistics.
Qualifications & Requirements
- Education: B.Pharm, M.Pharm, Pharm.D, or M.Sc in Clinical Research, Life Sciences, or a related discipline.
- Experience: 1–5 years of hands-on experience in clinical trial coordination, trial monitoring, or clinical research operations.
- Key Skills:
- Certification in Good Clinical Practice (GCP) preferred.
- In-depth knowledge of regulatory submission processes, clinical research ethics, and trial audit preparation.
- Strong clinical documentation skills, analytical precision, and clear interpersonal communication.
Pay: ₹40,000.00 - ₹60,000.00 per month
Benefits:
- Health insurance
- Leave encashment
- Life insurance
- Provident Fund
Ability to commute/relocate:
- Hyderabad, Telangana: Reliably commute or willing to relocate with an employer-provided relocation package (Preferred)
Education:
Location:
- Hyderabad, Telangana (Preferred)
Work Location: In person
