How to Apply

A cover letter is required for consideration for this position and should be attached as the first page of your resume. Applications receiving serious consideration will clearly address your interest in the position and specifically relate skills and experiences that are relevant to the required qualifications described in this posting.

Summary

The Department of Obstetrics and Gynecology is looking for an experienced compliance and regulatory specialist to work in collaboration with the Associate Chair for Research and Department Administrative Research Manager to support research faculty throughout the department. The idea candidate will have experience with IRB submissions and/or pre-review of human subjects’ applications ranging from multi-site clinical trials to observational studies and be comfortable with working on multiple projects simultaneously. This individual will assist faculty with writing the Human Subjects sections of federal grant submissions, Data Use/Material Transfer agreements, and navigating study start-up with the Clinical Trial Service Units (CTSU). This is primarily a remote position, but some onsite meetings are required throughout the year.

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

Responsibilities*

Regulatory Support

• Responsible for preparation and submission of Institutional Review Board (IRB) applications and associated documents for multiple studies and faculty, including but not limited to single IRB submission, multi-site studies, clinical trial studies, renewals, amendments, and SAE/ORIO/AE submissions
• Assist faculty, fellows, residents, and study teams with development of IRB protocols for various types of studies (clinical trials to observational)
• Assure appropriate regulations are followed and provide regulatory support on research activity within the department
• Train faculty, fellows, residents, and other investigators in IRB application and approval processes
• Responsible for IRB review and reporting, internal/external audits, study binder maintenance, and study team/sponsor meetings,
• Serve as liaison between faculty and IRB leadership and board and between subjects, investigators, other departments, and sponsors
• Monitor studies and prepare regulatory reports for senior management
• Coordinate with project managers at other institutions for multi-site studies to stay up to date on regulatory and study protocols
• Continually review and evaluate regulatory applications in order to identify problems, improve quality, and implement solutions or improvements
• Assure regulatory compliance and serve as member of oversight committee for programs such as the Labor and Delivery Tissue Committee and Biorepository
• Serve as liaison and coordinator between study team, IRB staff, and Labor and Delivery Tissue Committee for protocol, regulatory, and compliance questions and issues
• Identify any new projects that require review after initial enrollment to assure compliance with policies and standards
• Review all studies in the department on a yearly basis to assure compliance with protocol, institutional, and federal policies
• Assure compliance of all studies within the department regarding federal and institutional policies
• Prepare annual regulatory reports of research

Grant Support

• Assist faculty and study teams with Human Subjects sections of grant applications, including but not limited to enrollment tables, resources, inclusion of women and children, etc.
• Assist pre-award specialists on keeping resource sections of grants up to date and aligned with grant submission
• Assist pre/post award staff with responding to JIT in a timely manner with regulatory documentation and requirements
• Prepare draft IRB protocols based on Human Subjects sections of grants

CTSU Support

• Assist faculty with studies requiring CTSU review and oversight
• Ensure billing calendar accurately aligns with protocol
• Serve as liaison between investigators, study team, department, and CTSU
• Coordinate with Clinical Trials office, Office of Research, and others to ensure proper study implementation and conduct
• Ensure data is shared appropriate and data use agreements are in place
• Work within CTSU framework for initiation and oversight of multiple studies with billing calendars
• Work with division finance staff to assure tracking of patient visits matches finances for CTSU and non-CTSU projects
• Present project status to PIs and study teams

Unfunded Data Sharing/Material Transfer Agreements

• Using the eResearch Unfunded Agreements (UFA) system, assist faculty with Data Use, Material Transfer, and Non-Disclosure Agreements
• Create and maintain systems to track all department UFAs
• On a quarterly basis, compile and report newly executed agreements to Research Administration Manager and Associate Chair for Research
• Ensure timely execution of UFAs
• Guide, train, and onboard new and junior faculty on regulations and requirements for data and material sharing

Clinical Trials.gov

• Ensure department research faculty compliance with ClinicalTrials.gov regulations
• Register new trials in ClinicalTrials.gov
• Meet with faculty to review study and update records on existing trials, including monitoring IRB record for updates (add adverse events, changes to participants, protocol updates, etc.)
• Work with study team on obtaining results in timeline outlined by ClinicalTrials.gov
• Report results and finalize records for existing trials
• Attend trainings, workshops, and seminars to remain up to date on most recent compliance regulations

Other Duties

• Assist with study start-up and close-out meetings
• Identify studies within the department that need assistance and provide necessary resources to carry out study activities in compliance with institution, sponsor, and federal guidelines
• Analyze workflow and implement new systems and processes
• Other duties as assigned
• Coordinate with Office of Regulatory Affairs; attend trainings, workshops, and seminars to remain up to date on most recent compliance with regulations for IRB and clinical trials

Required Qualifications*

• Bachelor's degree or equivalent in education and experience.
• 3-5 years of related experience of which two years should be of prior research compliance oversight and/or research experience
• 2+ years’ recent experience with research administration
• Experience working on multi-site studies or single IRB applications
• Ability to perform primary activities independently and make decisions free from immediate direction
• Demonstrated problem-solving, conflict resolution, analytical, and critical thinking skills
• Demonstrated ability to work well under time constraints and meet deadlines
• Excellent computer skills including solid working knowledge of Microsoft Office Suite (Word, Excel, PowerPoint etc.)

Desired Qualifications*

• Background or experience in Women’s Health
• Previous experience with Data Use or Material Transfer Agreements
• Previous experience with ClinicalTrials.gov
• Previous experience with grant submissions
• Demonstrated ability to initiate activities and carry them through to completion, as well as the flexibility to change focus and priorities quickly
• Excellent communication skills, with the ability to receive and convey information clearly and concisely via various mediums
• Excellent interpersonal and organizational skills
• Ability to work effectively with diverse groups
• High degree of initiative and resourcefulness

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.

U-M COVID-19 Vaccination Policy

COVID-19 vaccinations, including boosters when eligible, are required for all University of Michigan students, faculty and staff across all campuses, including Michigan Medicine. This includes those working remotely. More information on this new policy is available on the Campus Blueprint website or the UM-Dearborn and UM-Flint websites.