Clinical Research Documentation Specialist

Job Title – Clinical Research Documentation Specialist

Position: Clinical Research Documentation Specialist
Department: Ethics Committee (EC) Division
Reporting To: Head – Ethics Committee Division
Location: Hyderabad
Salary: ₹17,000 – ₹22,000 per month
Working Hours: Day Shift; may include rotational shifts
Qualification: Doctor of Pharmacy (Pharm. D) – Mandatory
Experience: Freshers or up to 1 year in clinical research or healthcare industry preferred
Age Limit: 21–30 years (recommended)
Employment Agreement: Must agree to a 2-year employment agreement
Shift Flexibility: Must be willing to work in rotational shifts
Preferred Candidates: Male candidates preferred
Industry: Clinical Research Organization (CRO)
Immediate Joiners: Preferred

Freshers / Experience Note:

• Freshers or candidates with up to 1-year relevant experience are preferred.

Benefits:

• Structured learning and growth opportunities in clinical research documentation.
• Exposure to cross-functional activities across Ethics Committee and other divisions.
• Collaborative, professional, and supportive work environment.

Role Overview

The Clinical Research Documentation Specialist supports the Head of the Ethics Committee (EC) Division by ensuring all clinical research documentation is accurate, compliant, and audit-ready. The role involves managing end-to-end documentation processes in alignment with ICH-GCP, institutional, and ethical standards and supporting cross-functional requirements across departments as needed.

Detailed Roles & 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 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 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 SOPs, study protocols, and applicable regulatory standards.
• Maintain documentation for audit and inspection readiness.

4. Communication & Liaison

• Act as a liaison between clinical research teams and the Ethics Committee.
• Coordinate with investigators, sponsors, and regulatory bodies for documentation and submissions.

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.

Required 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, professionalism, and ethical integrity.

Additional 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