Director, Research Protocols and Compliance - Office of Women's Health

Wayne State University is searching for an experienced Director, Research Protocols and Compliance - Office of Women's Health at its Detroit campus location.

Essential functions (job duties):

Provides strategic leadership and operational oversight for the Office of Women's Health Research Programs and Synergy of Scholars for Maternal and Infant Health Equity (SOS MATERNITY) Network, ensuring stability, growth, and high-quality performance across all participating sites. This position manages and develops the Data Team of Research Associates and Research Assistants, directs all Institutional Review Board (IRB) Submissions and Regulatory and Compliance matters, and drives multi-site program management, improvements and expansion. Provides strategic and operational leadership of programs that improve maternal and fetal health for underrepresented minority women in Detroit and the State of Michigan. The Director, Research Protocols and Compliance reports to the Associate Vice President, Office of Women's Health.

Provides project management and operational leadership, collaborating with senior leadership to ensure quality outcomes for programs initiated by the Office of Women's Health and the Master of Public Health practicum. Develops metrics to gauge effectiveness, identifying continuous process improvements.

Supervision of Data Team Operations: Oversees data personnel, provides oversight and strategic supervision of data team operations, ensuring accurate data collection, management, reporting, integrity and workflow efficiency across projects and organizational initiatives. Leads cross-functional coordination, process improvement, quality control, and compliance with data governance standards to support informed decision-making and operational excellence. Supports data collection at Network sites throughout the state.

SOS Network Site Engagement: Leads Steering Committee meetings with the Principal Investigators. Leads one-on-one monthly meetings with each Patient Navigator in the SOS MATERNITY Network. Tracks enrollment for each site and troubleshoots with the site navigator to improve outcomes.

IRB, Regulatory and Compliance Management: Responsible for overseeing Institutional Review Board (IRB) documentation, regulatory submissions, and compliance processes to ensure research activities meet all federal, state, institutional, and ethical requirements. Manages protocol amendments, consent documentation, reporting obligations and cross-functional coordination to maintain regulatory readiness and support compliant clinical and research operations.

Site Expansion Support: Responsible for working with the main coordinator to hire a navigator for newly identified sites, identifies needs of each site, oversees training of the Patient Navigator at the Coordinating Center (Office of Women's Health at WSU) and leads site initiation visits at each clinical site.

Manages relationships with faculty, partnering departments, and external stakeholders to advance the mission of the research department and grow the research programs.

Perform other related duties as assigned.

Unique duties:

Qualifications:

Education: Bachelor's degree

• Bachelor's Degree from an accredited college or university. Master's degree preferred.

Experience: Intermediate (3 to 4 years job-related experience)

• Three or more years of experience in program management and research administration required.

• Considerable experience and knowledge in grant and contract administration as well as University information systems.

• Experience in pre-award activity and post-award activity, federal cost principles, research compliance, knowledge of federal agency practices, regulations and policies, and evidence of leadership success in comparable situations.

• Experience working on complex grant application submissions and management.

• Experience working with program officers at State, Federal, and other types of funding agencies and acting as an effective liaison between investigators and funding agencies.

KNOWLEDGE, SKILLS, AND ABILITIES:

Research Acumen:

• Extensive knowledge of Institutional Review Board (IRB) processes, regulatory requirements and compliance standards governing clinical and research activities (federal, state, and institutional).

• Knowledge of data governance principles, data integrity standards, and reporting requirements in clinical research environments.

• Comprehensive understanding of protocol development, amendments, informed consent processes and regulatory documentation.

• Knowledge of healthcare systems operations and patient navigation models across diverse clinical sites.

• Familiarity with NIH-sponsored and industry-sponsored research studies, including drug trials and large-scale network initiatives.

• Understanding of quality improvement methodologies and operational performance metrics in research programs.

• Skill in supervising, training, evaluating and developing teams; strong mentoring and coaching skills.

• Skill in project and program management, including coordinating cross-functional teams and managing competing priorities.

• Skill in data management oversight, including ensuring accurate data collection, reporting, workflow efficiency, and quality control.

Supervisory Skills: Ability to delegate work, set clear direction and manage workflow. Strong mentoring and coaching skills. Ability to motivate and train staff and develop subordinate's skills.

Communication Skills: Possess excellent verbal and written communication skills with all levels of employees, stakeholders and the public.

Customer Focus: Strong customer-service experience and focus.

Analytical and Problem-Solving Skills: Ability to problem solve and provide recommended courses of action and make sound judgments. Ability to multi-task in a fast-paced, often high stress, dead-line driven office environment is essential.

Computer Skills: Considerable skills with specialized software for preparation of spreadsheets, data tables, and graphic presentations so as to compile and analyze statistical data; knowledge of MS Word, Excel, Access, Powerpoint, Banner, Cognos, or similar system experience is a plus.

Preferred qualifications:

School/College/Division:

H39 - VP for Health Affairs
Primary department:

H3902 - Women's Health
Employment type:

• Regular Employee
• Job type: Full Time
• Job category: Staff/Administrative

Funding/salary information:

• Compensation type: Annual Salary

Working conditions:

Normal office environment. Occasional weekend work and extended hours may be required. Some local travel.
Job openings:

• Number of openings: 1
• Reposted position: No
• Reposted reason: None (New Requisition)
• Prior posting/requisition number: