Job Description

Position Title- Clinical Research Associate (CRA)/Pharmacist

Department- Clinical Affairs

Experience Requirement: 2-3 years

Qualification Requirement: B.Pharm/M.Pharm (Gujarat)

Profile Requirement:

Study Preparation and Initiation

1. Receive study-related documents from Quality Assurance and obtain required study documents (Protocol, Amendments, ICFs, IEC approvals, regulatory approvals, literature references, etc.) from Protocol writing team before study initiation.

2. Review study Protocols, CRFs, and related study documents for project-specific requirements.

3. Ensure that all study requirements are in place prior to study initiation.

4. Ensure that all personnel involved in the study are adequately trained on the approved Protocol, SOPs, and study-specific requirements.

Study Conduct and Clinical Oversight

1. Ensure compliance with Protocol, SOPs, GCP guidelines, and applicable regulatory requirements throughout the study.

2. Coordinate with the Study In-charge, Study Coordinator, Project Management, QA, and other departments for timely execution of study activities and submission of documents.

3. Coordinate with Ethics Committee, Sponsors, Emergency Hospitals and other study related stakeholders whenever required.

4. Present the Informed Consent Form (ICF) and obtain informed consent from volunteers, including audio-video recording wherever applicable.

5. Perform Dosing activity,



Sample processing activity whenever required.

6. Monitor study activities and evaluate protocol execution.

7. Escalate critical observations, protocol deviations, and compliance concerns to the project team and management.

Pharmacy Management

1. Accept and verify Investigational Products (IPs) received for clinical studies.

2. Prepare and control investigational product dispensing labels as per approved procedures.

3. Dispense investigational products as per the approved randomization schedule.

4. Maintain accountability, reconciliation, storage, and inventory records of investigational products.

5. Ensure proper maintenance, cleanliness, security, and overall operation of the pharmacy area.

6. Maintain pharmacy-related logs, records, and documentation in compliance with applicable procedures.

Reporting, Compliance and Audit Support

1. Prepare study interim reports, clinical updates, and study status reports and submit them to the concerned departments.

2. Provide compliance responses and corrective actions for audit observations issued by QA, sponsors, clients, or regulatory authorities.

3. Support audits, inspections, and regulatory assessments and ensure timely closure of observations.

4. Ensure inspection readiness and maintain compliance with applicable quality and regulatory requirements.

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