Project Coordinator (Clinical Operations)

Key Responsibilities

• Manage clinical trial activities including PSSV, SIV, Monitoring, and Close-out.
• Ensure compliance with Protocol, SOPs, GCP, ICH-GCP, NDCT Rules 2019, and applicable regulatory requirements.
• Monitor patient recruitment, retention, and study timelines.
• Ensure timely EDC completion, source documentation, query resolution, and reporting of SAE/SUSAR/protocol deviations.
• Maintain ISF, essential documents, and continuous audit/inspection readiness.
• Coordinate with PI, CRA, Sponsors/CROs, and internal teams.
• Supervise CRCs, monitor KRAs/KPIs, conduct QC, and ensure timely task completion.
• Conduct feasibility assessments and support new site onboarding/activation.
• Ensure patient safety, informed consent, ethics, and IEC/EC compliance.
• Identify project risks, resolve operational issues, and ensure timely escalation and CAPA closure.

Experience & Requirements

• Minimum 5 years of Clinical Operations experience as a CRC, Sr. CRC or site lead
• Experience in multi-site operations, team handling, recruitment, documentation, and regulatory compliance preferred.
• Willingness to travel across Maharashtra and relocate to Nagpur, if required.