Regulatory Manager - Dept of Medicine

The Department of Medicine (DOM), in collaboration with the UW Clinical Trials Institute (CTI), has developed a shared infrastructure to promote and support clinical research activities across DOM. This partnership encourages clinical research professionals and participants to advance discovery and research in the prevention, detection, and treatment of disease to help improve the health of individuals, families, and communities across Wisconsin and beyond. Our exceptionally talented workforce provides care, support, and information to clinical trials participants; resources, training, and guidance to research professionals; and opportunities for industry partners to advance groundbreaking medical research.

The Department of Medicine (DOM) is seeking a Regulatory Manager to lead a team in providing comprehensive support services to faculty conducting clinical research. This position will work closely with investigators, research coordinators, industry sponsors, contract research organizations and others to coordinate the preparation of documents necessary to obtain and maintain protocol approval from various Institutional Review Boards (e.g., UW Health Sciences, commercial, VA) and research oversight bodies.

The incumbent will serve as a subject matter expert providing regulatory leadership, training, and consultation to DOM's faculty, staff, and trainees. This position will be expected to serve in a variety of capacities, including but not limited to, preparation and submission of protocols and compliance documents, tracking and meeting renewal deadlines, collection and maintenance of research records and consent documentation, review of study proposals to ensure compliance, assisting investigators and staff to assess regulatory feasibility of new studies, providing guidance on submission of serious adverse event reports, unanticipated problems, protocol deviations, and other reports required by regulatory organizations, and the training of investigators and staff on regulatory requirements.

The incumbent will serve as a member of DOM's Office of Research Services (ORS) and report to DOM's Associate Director for Research. In addition, the position will work collaboratively and in close partnership with the CTI Regulatory Supervisor to ensure alignment with the research goals of both units. Beyond the duties described, this position will have opportunities to identify, lead and/or participate in regulatory related initiatives. In partnership with DOM and ORS leadership, the incumbent will provide operational support in initiatives to help drive the growth and performance of DOM's clinical research program.

• 15% Oversees planning, development, implementation, and management of a regulatory office
• 10% Develops and implements service strategies to meet needs of researchers and staff
• 5% May exercise supervisory authority, including hiring, transferring, suspending, promoting, managing conduct and performance, discharging, assigning, rewarding, disciplining, and/or approving hours worked of at least 2.0 FTE or equivalent employees
• 25% Ensures adherence to all research standards as set forth by all pertinent regulatory agencies
• 30% Directs regulatory work for a variety of research studies for research teams and investigators
• 10% Develops and maintains procedures for regulatory document submission and retention processes
• 5% Oversees the regulatory-related training curriculum for a regulatory team

Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.

The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.

For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion

Preferred
Bachelor's Degree in business/public administration, public health, clinical research or related field or equivalent experience

Required:
- At least 5 years of experience in research compliance activities related to IRB submissions for clinical trial research.
- At least 5 years of experience in regulatory oversight activities, and familiarity with university organizational policies and procedures.
- Relevant experience in an academic medical center or academic clinical research setting

Preferred:
- Knowledge of the following regulations and guidelines: University, State, FDA, ClinicalTrials.gov, Good Clinical Practice (GCP) Guidelines, Health Information and Accountability (HIPAA), Code of Federal Regulations and The Protection of Human Research Subjects
- Familiarity and/or experience with UW research infrastructure (e.g., Research and Sponsored Programs, ARROW), IRB submissions, budget development and budget negotiations

Ideal candidates will have:
- Ability to listen, understand and communicate information and ideas effectively in writing, over the phone or in person.
- Ability to consistently deliver high quality, accurate, and compliant work
- Comfort in exercising independent discretion
- Ability to work collaboratively as part of a team and with medical faculty to facilitate research
- Attention to detail and ability to simultaneously manage many detailed projects and meet deadlines
- Excellent time management skills and ability to prioritize and manage multiple projects despite interruptions, while closely tracking details and looking for ways to improve processes.

Full or Part Time: 80% - 100%

This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location. The balance of in-person and remote work schedule for this position will be discussed at the time of hire.

Ongoing/Renewable

Minimum $75,000 ANNUAL (12 months)
Depending on Qualifications
The starting salary for the position is $75,000 but is negotiable based on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at (https://hr.wisc.edu/benefits/).

University sponsorship is not available for this position, including transfers of sponsorship. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require continuous work eligibility. UW-Madison is not an E-Verify employer, and therefore, is not eligible to employ F1 STEM OPT Extension participants. If you are selected for this position you must provide proof of work authorization and eligibility to work.

To apply for this position, please click on the "Apply Now" button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications and experience.

Calleen Roper
croper@medicine.wisc.edu
608-262-8108
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Regulatory Manager(CP086)

A53-MEDICAL SCHOOL/MEDICINE/MEDICINE

Academic Staff-Renewable

309677-AS