Clinical Research Operations Manager II for the Pediatric Trial Network (PTN) Resume Example

Clinical Research Operations Manager for the Pediatric Trial Network (PTN) Department of Research Development and Clinical Investigation

• Collaborates with professional staff to plan, supervise and evaluate all aspects of the clinical and research operations conducted by the NICHD-sponsored Pediatric Trial Network.
• Provides programmatic direction and general programmatic supervision of all departmental clinical research coordinators, and staff in cooperation with the Chief Scientific Officer (CSO) who serves as the site Core Director of the Pediatric Trial Network (PTN).
• Acts as research liaison with outside institutions, and mentors internal departments regarding research activities related to the PTN.
• Assist in the development of appropriate training operational tools, resources and capabilities that foster consistency, efficiency, and strong relationships between internal and external partners, research sites, and the PTN.
• Overall trial management of the PTN through interfacing and or collaboration with Medical Research Administration and mentoring of assigned research coordinators to ensure that tasks are performed with quality, on schedule, within budget, and in compliance with applicable regulatory requirements, in accordance with PTN policies.
• Assuring compliance with applicable Internal Review Board (IRB), Institutional Bio Safety Committee (IBC), and HIPAA Privacy and Security requirements.
• Provides programmatic direction and general programmatic supervision of all departmental clinical research coordinators, and staff in cooperation with the Chairman of the Department of Medical Research who serves as the site Core Director of the Pediatric Trial Network (PTN).