Manager, Division of Clinical Research (Regulatory)

Washington University School of Medicine

Position coordinates and assists with various aspects of Oncology research including completing IRB paperwork and other activities associated with the administrative start-up and maintenance of all studies. This position also performs duties associated with the regulatory coordination and implementation of clinical trials for institutional studies, cooperative group studies and pharmaceutical industry-sponsored studies for Oncology. Extensive interaction with the Internal Review Board (IRB), study sponsors, and investigators is expected.

1. Responsible for the management of the Division of Clinical Research and the day-to-day functions of the division
2. Responsible for recruiting, hiring, managing, and review of clinical research staff, including salary sourcing decisions with participation of
3. Makes recommendations and participates in the development of and implements decisions and policies and procedures for the clinical research division
4. Communicates with IRB, PRMC & QASM Committees as needed to handle protocol specific
5. Monitors compliance of the clinical research division with the IRB, federal mandates, and grant compliance; identifies areas needing improvement and suggests solutions to problems
6. Assists with compliance monitoring and audits
7.Acts as liaison in matters relating to clinical research activities between the department, the School of Medicine, and external agencies

MINIMUM EDUCATION/EXPERIENCE: Bachelorís degree, preferably in Business Administration or related field, plus a minimum of 4 years of experience in management, and direct experience in research-related activities

CRITICAL SKILLS AND EXPERTISE: Ability to take action in solving problems while exhibiting judgment and a realistic understanding of issues; ability to organize or schedule people or tasks, to develop realistic plans while being sensitive to the needs of different constituencies, time constraints, and resource availability; ability to communicate verbally and in writing clearly and effectively, presenting ideas, documenting activities, reading and interpreting written information such as federal, state, and internal guidelines and requirements