Immediate Joiners

Job Summary:
We are looking for a motivated and detail-oriented Clinical Research Associate (CRA) - I to join our Clinical Research Operations team. The CRA will be responsible for monitoring clinical trial sites to ensure compliance with study protocols, Valuable Clinical Practice (GCP), and regulatory requirements. This role involves close collaboration with site staff, project managers, and cross-functional teams to support the successful execution of clinical studies.

Key Responsibilities:
- Perform site monitoring visits (pre-study, initiation, routine, and close-out) in accordance with the monitoring plan.
- Assist in site selection and feasibility assessments.
- Ensure trial sites adhere to the study protocol, SOPs, and applicable regulatory guidelines. Verify source documents and ensure accurate data collection and reporting.
- Maintain regular communication with site staff to ensure smooth trial conduct and resolve issues proactively.
- Document and report findings in visit reports and follow-up letters.




- Support site start-up activities including document collection and regulatory submissions.
- Coordinate with clinical project teams and contribute to team meetings.
- Maintain study documentation and Trial Master File (TMF) compliance.
- Willingness to travel for site visits and monitoring activities as required by the study.
- Ensure timely identification, documentation, and escalation of protocol deviations, safety concerns, or compliance issues.
- Contribute to audit readiness by ensuring all monitoring and site activities are well documented and compliant.
- Provide input to improve study tools, processes, or monitoring practices based on site feedback and field experience.
- Support timely resolution of site queries and follow-up on pending actions from monitoring visits.
- Maintain continuous awareness of project timelines and deliverables, and take responsibility for meeting assigned milestones.

Skills:
- Excellent communication an

📌 Clinical Research Associate- I (Karve Nagar)
🏢 ProRelix Research
📍 Karve Nagar