Clinical Research Documentation Specialist

Role Overview:
The Clinical Research Documentation Specialist supporting the Head of the Ethics Committee (EC) Division plays a key role in ensuring all documentation is accurate, compliant, and audit-ready. This position requires managing end-to-end responsibilities related to clinical research documentation in alignment with regulatory, institutional, and ethical guidelines.

End-to-End Responsibilities:

Regulatory Document Management:

• Maintain essential trial documents as per ICH-GCP guidelines.
• Prepare and update Investigator Site Files (ISFs) and Trial Master Files (TMFs).
• Ensure timely submission of study protocols, amendments, and informed consent forms to the Ethics Committee.
• Ethics Committee Coordination:
• Assist in the preparation of EC meeting agendas, presentations, and minutes.
• Track and manage EC approvals, re-approvals, and continuing reviews.
• Ensure documentation of decisions and communications is accurate and up to date.
• Protocol & SOP Compliance:
• Ensure study-related activities align with standard operating procedures (SOPs), protocols, and regulatory requirements.
• Prepare documentation to demonstrate compliance during audits or inspections.
• Communication and Liaison:
• Act as a bridge between the clinical research team and the EC.
• Coordinate with investigators, sponsors, and regulatory bodies for documentation needs.
• Audit & Inspection Readiness:
• Support internal and external audits by providing required documentation.
• Implement corrective and preventive actions (CAPA) as per audit findings.
• Training & Documentation Support:
• Provide training on documentation practices and GCP compliance.
• Assist in drafting SOPs related to documentation and EC processes.
• Archival & Record Management:
• Manage secure archival of all EC and trial-related documents.
• Ensure document retention policies are followed.

Job Type: Full-time

Pay: ₹18,000.00 - ₹22,000.00 per month

Benefits:

• Health insurance
• Provident Fund

Schedule:

• Day shift
• Rotational shift

Supplemental Pay:

• Joining bonus
• Overtime pay
• Performance bonus
• Yearly bonus

Work Location: In person