Job Description

Role & responsibilities Study Site Management & Regulatory Compliance Conducting initiation visits to ensure sites are prepared for the trial. Regularly visiting study sites to ensure compliance with the protocol, Good Clinical Practice (GCP), and regulatory requirements. Ensuring that the study is conducted in accordance with the approved protocol and amendments. Verifying that informed consent is obtained from all study participants. Data Quality and Integrity Risk Management Implementing corrective and preventive actions (CAPA) to resolve issues and prevent recurrence. Documentation and Reporting - Ensuring all trial-related documentation is complete, accurate, and up-to-date. Preparing monitoring reports, site visit reports, and other required documentation. Patient Safety and Rights - Monitoring and reporting adverse events and serious adverse events (SAEs) in accordance with regulatory requirements. Ensuring the safety and well-being of study participants throughout the trial. Preferred candidate profile Masters in Science / PHD / Relevant qualification in Clinical Research Should have lead a team of CRC in past for minimum 3 - 4 years Perks and benefits Best in Industry Share resume on neha.yadav@indiraivf.in