Clinical Research Documentation Specialist

5 days ago

Ameerpet Hyderabad Telangana, India Forward Life Pvt. Ltd Full time ₹ 2,64,000 per year

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.

Notes

  • Need to do Cross functional, whenever other division/departments requires support
  • Need to agree with 2 year agreement
  • Should be okay with rotational shifts

Job Type: Full-time

Pay: ₹18, ₹22,000.00 per month

Benefits:

  • Health insurance
  • Provident Fund

Work Location: In person

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