Clinical Research Documentation Specialist

Position: Clinical Research Documentation Specialist

Department: Ethics Committee (EC) Division

Reporting To: Head – Ethics Committee Division

Role Overview

The Clinical Research Documentation Specialist plays a critical role in supporting the Head of the Ethics Committee (EC) Division) by ensuring all clinical research documentation is accurate, compliant, and audit-ready.

This role manages end-to-end documentation processes in alignment with ICH-GCP, institutional, and ethical standards and supports cross-functional needs across departments when required.

Key Responsibilities

1. Regulatory Document Management

Maintain and update essential trial documents in compliance with ICH-GCP guidelines.

Prepare, organize, and manage Investigator Site Files (ISFs) and Trial Master Files (TMFs).

Ensure timely and accurate submission of study protocols, amendments, and informed consent forms to the Ethics Committee.

2. Ethics Committee Coordination

Assist in preparing EC meeting agendas, presentations, and minutes.

Track and manage approvals, re-approvals, and continuing reviews of studies.

Maintain precise documentation of EC decisions, communications, and correspondence.

3. Protocol & SOP Compliance

Ensure all activities adhere to Standard Operating Procedures (SOPs), protocols, and applicable regulatory standards.

Maintain documentation for audit and inspection readiness.

4. Communication & Liaison

Act as a liaison between the clinical research teams and the Ethics Committee.

Coordinate with investigators, sponsors, and regulatory bodies for documentation and submission needs.

5. Audit & Inspection Readiness

Support internal and external audits by providing organized and accurate documentation.

Implement Corrective and Preventive Actions (CAPA) in response to audit observations.

6. Training & Documentation Support

Conduct or assist with training sessions on documentation standards, GCP, and EC processes.

Contribute to drafting, reviewing, and updating SOPs related to EC documentation.

7. Archival & Record Management

Manage secure archival and retrieval of all EC and trial-related documents.

Ensure adherence to document retention and confidentiality policies.

Educational Qualification

Mandatory Qualification: Doctor of Pharmacy (Pharm D)

Preferred Candidates: Male candidates only

Must be willing to sign a 2-year service agreement.

Must be comfortable working in rotational shifts.

Skills & Competencies

Strong understanding of ICH-GCP and clinical research regulations.

Excellent documentation and organizational skills.

Proficiency in MS Office and document management systems.

Strong attention to detail and accuracy.

Effective communication and coordination skills.

Ability to work cross-functionally and manage multiple priorities.

Knowledge of audit and inspection processes.

High level of confidentiality and ethical integrity.

Notes

This is a cross-functional support role; the candidate may assist other divisions or departments as required.

The position contributes to ensuring all EC and clinical research documentation is audit-ready, compliant, and aligned with institutional goals.

Job Type: Full-time

Pay: ₹204,000.00 - ₹264,000.00 per year

Benefits:

• Health insurance
• Provident Fund

Work Location: In person