Clinical Research jobs in Bengaluru, Karnataka

Job Title: Clinical Research Associate

Department: Clinical Operations

Location: Bengaluru, Karnataka Reports To: Sr Project Manager

Job Summary

The Clinical Research Associate (CRA) ensures the smooth execution of clinical trials by managing compliance, site coordination, data management, and ethical oversight. This role involves collaborating with investigators, sponsors, and regulatory bodies to maintain protocol adherence, patient safety, and GCP compliance while overseeing study logistics and documentation.

Key Responsibilities1. Regulatory Compliance:

· Ensure compliance with general and study specific regulatory requirements

· Conduct study activities in alignment with local, federal, and state regulations and institutional policies.

· Submission of EC Dossier and coordination with IEC/IRB to get approvals for the Clinical Trial Conduct.

2. Site Management:

· Coordinate and execute site selection, initiation and close-out visits.

· Conduct training for site staff on trial-specific industry standards and procedure.

3. Study Coordination:

· Facilitate daily clinical trial activities, including scheduling study subject appointments and serving as a liaison between patients, principal investigators (PIs) and other study personnel.

· Support the informed consent process by clearly communicating study protocols and answering questions from potential subjects.

4. Participant Management & Communication:

· Facilitate clear and effective communication with CROs, sponsors, investigators, research teams, laboratories, and vendors.

· Serve as the primary contact for study-related inquiries from sponsors, and regulatory authorities.

5. Data Management:

· Maintain and manage study records, including Case Report Forms (CRFs), Drug Dispensation Records and Regulatory Forms.

6. Communication:

· Serve as the primary contact for study sites, CROs, sponsors, Vendors, ensuring timely communication and support.

7. Ethics and Oversight:

· Coordinate with ethics committees to ensure the rights and welfare of study participants are safeguarded.

· Report any suspicion of research misconduct to promote ethical research conduct.

8. Documentation and Reporting:

· Review the data collated by the CRC and ensure completeness and accuracy.

· Aid in archival of study documentation.

· Write visit reports and maintain comprehensive records of trial related activities.

9. Protocol Development:

· Assist in the development of trial protocols, including methodology and data collection forms (CRFs)

10. Inventory and IP Management:

· Oversee investigational product (IP) management, including receipt, storage, dispensation, and accountability.

· Manage investigational product (IP) supplies, ensuring all materials are accounted for and properly distributed to trial sites.

· Coordinate the close-down of trial sites upon completion of the study.

Secondary Responsibilities:

1. Ensuring Compliance with SOP’s, Legal Regulations, ICH and GCP guidelines

2. Overall Responsibilities: Protocol Compliance, GCP compliance, GDP compliance, SOP compliance.

Pay: ₹500,000.00 - ₹600,000.00 per year

Benefits:

• Cell phone reimbursement
• Paid time off
• Provident Fund

Work Location: In person