Clinical Research Associate

Proxima Skills Training & Consulting Services (opc); Ernakulam, Chennai, Bengaluru; On-site; INR 600,000 - 900,000; Full time

Job summary

Proxima Skills Training & Consulting Services (opc) is seeking detail-oriented Clinical Research Associates to support clinical trials, ensure GCP compliance, and follow regulatory requirements and study protocols.

You will monitor sites, manage TMF, coordinate with investigators and sponsors, verify data quality, and assist in safety and regulatory reporting. Experience with site visits and documentation control is preferred; strong attention to detail and teamwork are essential.

Responsibilities

• Monitor clinical trial sites to ensure compliance with study protocols and GCP guidelines.
• Assist in site selection, initiation, monitoring, and close-out visits.
• Verify clinical trial data for accuracy, completeness, and consistency.
• Maintain Trial Master Files (TMF) and essential study documentation.
• Coordinate with investigators, site staff, sponsors, and clinical research teams.
• Identify protocol deviations and support their resolution.
• Ensure participant safety, confidentiality, and proper informed consent documentation.
• Prepare monitoring visit reports and follow up on outstanding action items.
• Support regulatory documentation and clinical trial reporting activities.

Job description

Job Summary

We are looking for detail-oriented and motivated Clinical Research Associates (CRAs) to support clinical trials and ensure compliance with Good Clinical Practice (GCP), applicable regulatory requirements, and clinical study protocols.

Key Responsibilities

• Monitor clinical trial sites to ensure compliance with study protocols and GCP guidelines.
• Assist in site selection, initiation, monitoring, and close-out visits.
• Verify clinical trial data for accuracy, completeness, and consistency.
• Maintain Trial Master Files (TMF) and essential study documentation.
• Coordinate with investigators, site staff, sponsors, and clinical research teams.
• Identify protocol deviations and support their resolution.
• Ensure participant safety, confidentiality, and proper informed consent documentation.
• Prepare monitoring visit reports and follow up on outstanding action items.
• Support regulatory documentation and clinical trial reporting activities.