Clinical Research Monitor / CRA / Project Manager

Job Description

Description The Clinical Research Monitor / CRA / Site Monitor will coordinate clinical studies and shall be responsible for study execution, monitoring, site-training and close-out. Responsibilities will include: 1. Managing execution of clinical trial projects from initiation to closeout - across multiple projects, sites and teams. 2. Managing site relationships for ensuring and securing compliance with regulations, budgets and timelines. 3. Providing operational insights for compliance with Protocol, SOPs, policies and practices. 4. Collaborating with project teams and sponsors. 5. Site qualification, contract negotiation, IRB/EC submissions, study initiation, monitoring, and site close-out. 6. Training and oversight of site staff. 7. Periodic reviews of site-level KRIs. 8. Early identification of site-level risk/issue(s) occurring during study conduct; Escalating issues to project teams. 9. Maintaining Trial Master File (TMF). 10. Coordinating study supplies, biospecimen management, and coordination with various stakeholders. 11. Data query resolutions. 12. Supporting audit readiness and preparations. 13. Preparing study progress and performance metrics. 14. Travel to investigative sites (up to 25%). Desired Candidate Profile 1. Rich experience in clinical research operations and project management, preferably in global clinical trials. 2. A degree in medicine, pharmacy or life sciences. 3. In-depth understanding of clinical research regulations, industry standards and GCP. 4. Excellent verbal and written communication skills. 5. Proficiency in using MS Word & MS Excel. Job Type: Full-time Pay: ₹600,000.00 - ₹1,000,000.00 per year Schedule: Day shift Work Location: In person