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.
EDUCATION REQUIRED:
Bachelor's degree in a related field.
EXPERIENCE REQUIRED:
Five (5) years industry experience or academic clinical research experience.
Experience to drive project milestones and lead multi-disciplinary teams.
Contribution to the successful strategic development of compounds through phases of clinical research.
Open, collaborative, transparent working style.
Ability to synthesize and explain complex topics to non-experts.
Ability to collaborate effectively with all personnel involved in clinical research.
Strong analytical skills including the assessment of scientific data and medical literature.
Excellent written and verbal communication skills.
Knowledge of applicable regulatory, quality and compliance standards.
CERTIFICATIONS/LICENSURES REQUIRED:
Research certification (e.g., CCRP, ACRP, etc.) required. If the applicant does not have a research certification (e.g., CCRP, ACRP, etc.), they must obtain certification within six months of employment.
Additional Details
This posting represents the major duties, responsibilities, and authorities of this job, and is not intended to be a complete list of all tasks and functions. It should be understood, therefore, that incumbents may be asked to perform job-related duties beyond those explicitly described above.
Overview
Henry Ford Health partners with millions of people on their health journey, across Michigan and around the world. We offer a full continuum of services – from primary and preventative care to complex and specialty care, health insurance, a full suite of home health offerings, virtual care, pharmacy, eye care and other health care retail. With former Ascension southeast Michigan and Flint region locations now part of our team, Henry Ford’s care is available in 13 hospitals and hundreds of ambulatory care locations. Based in Detroit, Henry Ford is one of the nation’s most respected academic medical centers and is leading the Future of Health: Detroit, a $3 billion investment anchored by a reimagined Henry Ford academic healthcare campus. Learn more at henryford.com/careers.
Benefits
The health and overall well-being of our team members is our priority. That’s why we offer support in the various components of our team’s well-being: physical, emotional, social, financial and spiritual. Our Total Rewards program includes competitive health plan options, with three consumer-driven health plans (CDHPs), a PPO plan and an HMO plan. Our team members enjoy a number of additional benefits, ranging from dental and eye care coverage to tuition assistance, family forming benefits, discounts to dozens of businesses and more. Employees classified as contingent status are not eligible for benefits.
Equal Employment Opportunity/Affirmative Action Employer
Equal Employment Opportunity / Affirmative Action Employer Henry Ford Health is
committed to the hiring, advancement and fair treatment of all individuals without regard to
race, color, creed, religion, age, sex, national origin, disability, veteran status, size, height,
weight, marital status, family status, gender identity, sexual orientation, and genetic information,
or any other protected status in accordance with applicable federal and state laws.