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
The Clinical Research Monitor / CRA / Site Monitor will coordinate clinical studies and shall be responsible for study execution, monitoring, site-training, and close-out. You will be managing the execution of clinical trial projects from initiation to closeout across multiple projects, sites, and teams. Additionally, you will be responsible for managing site relationships to ensure compliance with regulations, budgets, and timelines. Providing operational insights for compliance with Protocol, SOPs, policies, and practices will be a key aspect of your role. Collaboration with project teams and sponsors is also expected. Your responsibilities will include site qualification, contract negotiation, IRB/EC submissions, study initiation, monitoring, and site close-out. You will also be involved in the training and oversight of site staff, periodic reviews of site-level KRIs, and early identification of site-level risks/issues occurring during study conduct with appropriate escalation to project teams. Maintaining the Trial Master File (TMF), coordinating study supplies, biospecimen management, and liaising with various stakeholders are integral parts of this role. Data query resolutions, supporting audit readiness and preparations, preparing study progress and performance metrics, and occasional travel to investigative sites (up to 25%) will also be part of your responsibilities. The ideal candidate should have rich experience in clinical research operations and project management, preferably in global clinical trials. A degree in medicine, pharmacy, or life sciences is required. An in-depth understanding of clinical research regulations, industry standards, and Good Clinical Practice (GCP) is essential. Excellent verbal and written communication skills, as well as proficiency in using MS Word & MS Excel, are necessary for this role. This is a full-time position with a day shift schedule and requires in-person work at the designated location.,
As a driver for this position, you will be responsible for maintaining the cleanliness and hygiene of the vehicle to ensure it is presentable at all times. A valid driving license is a must-have requirement for this role, along with a strong understanding of traffic rules and regulations. Proficiency in using navigational tools such as GPS is essential to navigate efficiently to different destinations. Your excellent driving skills will be crucial in ensuring safe and timely transportation for passengers or goods. This is a full-time position with a day shift schedule. The work location will be in-person, and accommodation will be provided at our premises in Delhi.,