KEY ROLES &

• RESPONSIBILITIES:1.

Clinical Trial

Management:Coordinate and manage all phases of clinical trials conducted at Charak Hospital as per protocol.Assist Principal Investigator (PI) in feasibility assessment, site initiation, and trial execution.Ensure all trials are conducted in compliance with ICH-GCP, ICMR Ethical Guidelines, and New Drugs &

- Clinical Trial Rules.2. Documentation &
- Regulatory Compliance:Prepare, maintain and update all essential trial documents - Trial Master File (TMF), Investigator Site File (ISF), Informed Consent Forms (ICF), Case Report Forms (CRF).Prepare documents for Ethics Committee (EC) submission, approval, amendments, and SAE reporting.Coordinate with DCGI / CDSCO, Institutional Ethics Committee (IEC) for approvals and renewals.Maintain confidentiality of research data and patient information.3. Site Monitoring &
- Data Management:Perform site monitoring visits (SIV, SMV, SCV, COV).Ensure accurate data entry in CRF / eCRF and resolve queries in coordination with data management team.Ensure Serious Adverse Event (SAE) identification,



documentation and timely reporting to Sponsor, Ethics Committee and regulatory authorities.4. Coordination &
- Liasioning:Act as a bridge between Principal Investigator, Sponsor/CRO, Ethics Committee, Laboratory, Pharmacy and patients.Coordinate with doctors, nursing, lab and pharmacy for Investigational Product (IP) handling, storage, dispensing and accountability.Counsel and recruit eligible patients / volunteers as per inclusion/exclusion criteria and take informed consent.5. Academic &
- Research Development:Support in development of recent research proposals, protocols and SOPs for the research department.Assist in conducting CME, workshops and training of hospital staff on GCP and research methodology.Prepare monthly research status reports, enrolment logs and submit to management.

Pay: ₹15,000.00 - ₹20,000.00 per month

Benefits

- Cell phone reimbursement

Work Location: In person

📌 Clinical Research Associate (Lucknow)
🏢 Charak Hospital u0026 Research centre
📍 Lucknow