Clinical Research Monitor / CRA / Project Manager Apothecaries Clinical Research

5.0 - 9.0 years

0 Lacs

haryana

On-site

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.,

Posted 6 days ago

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