Job Title – Documentation Specialist

Position: Clinical Research Documentation Specialist

Location: Hyderabad

Salary: ₹18,000 – ₹22,000 per month

Working Hours: 9:30AM-6:30PM; Must be willing to work in rotational shifts

Qualification: Doctor of Pharmacy (Pharm. D) – Mandatory

Experience: Freshers or up to 1 year in clinical research or healthcare industry preferred

Employment Agreement: Must agree to a 3-year employment agreement

Industry: Clinical Research Organization (CRO)

Immediate Joiners: 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 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

- Coordinate Serious Adverse Event (SAE) reporting to regulatory authorities through the portal within stipulated timelines, ensuring accuracy and completeness of documentation.
- Support Ethics Committee registration, re-registration, and related submissions in accordance with CDSCO requirements. Ethics Committee Coordination.
- Support and facilitate regulatory audits/inspections by ensuring audit readiness, coordinating requirements, responding to auditor queries, and assisting in CAPA closure

1. 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.

1.



Protocol & SOP Compliance

- Ensure all activities adhere to SOPs, study protocols, and applicable regulatory standards.
- Maintain documentation for audit and inspection readiness.

1. 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.

1. 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.

1. 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.

1. 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 Types: Full-time, Permanent, Fresher, Onsite

Advantages

- Health insurance
- Provident Fund

Job Types: Full-time, Permanent Pay: ₹18,000.00 - ₹22,000.00 per month

Benefits

- Health insurance
- Provident Fund

Work Location: In person

📌 Documentation Specialist (Ameerpet)
🏢 FORWARD LIFE PVT.LTD
📍 Ameerpet