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 recent 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.

📌 Project Coordinator (Clinical Operations) (Nagpur)
🏢 Canvass Clinical Research Services
📍 Nagpur