Manager-Quality & Regulatory CCTRO- Regulatory Manager - 40 Hours - Days

The Cancer Clinical and Translational Research Office (CCTRO) is the largest clinical research department at Henry Ford Health System. We manage approximately 200 ongoing trials that focus on the prevention, diagnosis, treatment and cure of cancer. Our staff have highly specialized roles in clinical coordination, research nursing, data management, regulatory coordination, grant management, and research sample processing. This is a fast growing program that is working with the Henry Ford Health and Michigan State University Health Sciences Partnership toward National Cancer Institute designation. The CCTRO is very team driven and passionate about providing high quality care to our patients and excellent support to our physician investigators.

The CCTRO is seeking an experienced Regulatory Manager to join our growing cancer clinical research team. We seek a candidate who has at least 3 years of IRB experience or experience in clinical trials regulatory document management, preferably in cancer clinical trials. The position requires research certification from SOCRA or ACRP. Leadership experience, NCI Comprehensive Cancer Center experience, cooperative group, IIT, Industry trial management experience, and OnCore and eReg CTMS experience are preferred. This leadership position will work closely with the other leaders of the CCTRO and Cancer Service Line. The position requires a team focus, strong organizational skills, the ability to take the lead on complex projects, attention to detail and the ability to see the larger picture of the operations and goals of the CCTRO. The ideal candidate is adaptable and possesses the ability to multitask. The Manager CCTRO Quality & Regulatory will oversee see a team of regulatory coordinators and will be responsible for training new staff.

GENERAL SUMMARY:

The Manager-Quality & Regulatory-Clinical and Translational Research Office (CCTRO) is responsible for establishing and monitoring the policies and procedures that govern Clinical and Translational Research within Henry Ford Health Cancer. Reports to the Director-Cancer Clinical & Translations Research and works directly with the Medical Director of the CCTRO to develop and improve the quality and regulatory structure for clinical trials and research.

This includes the creation of:

• Appointments,

• Committees,

• Regulatory oversight,

• Quality assurance

• Standard operations procedures necessary for Henry Ford Health Cancer to conduct clinical trials consistent with current regulatory and ethical standards.

• The overarching goal of Henry Ford Health Cancer is to be the destination for cancer clinical care and transformational research and Clinical Trials are viewed as a critical component of that overarching mission.