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

Wayne State University
  • Detroit, MI
    2 days ago

    Job Description

    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.

    Numbers & Facts

    LocationDetroit, MI
    IndustryEducation
    Company Size5,000 to 9,999 employees
    Year Founded1868
    Websitehttp://wayne.edu
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    Skills

    • Clinical Researchunmatched
    • Clinical Trialunmatched
    • Cross-Functionalunmatched
    • Data Collectionunmatched
    • Data Managementunmatched
    • Data Qualityunmatched
    • Decision Supportunmatched
    • Documentationunmatched
    • IRB/IEC (Institutional Review Board/Independent Ethics Committee)unmatched
    • Identify Issuesunmatched
    • Lead Generationunmatched
    • Leadershipunmatched
    • Maintain Complianceunmatched
    • Management Strategyunmatched
    • Metricsunmatched
    • Needs Assessmentunmatched
    • Network Monitoringunmatched
    • Operational Strategyunmatched
    • Operational Supportunmatched
    • Operations Managementunmatched
    • Operations Researchunmatched
    • Organizational Skillsunmatched
    • Process Developmentunmatched
    • Process Improvementunmatched
    • Process Managementunmatched
    • Project/Program Managementunmatched
    • Public Healthunmatched
    • Quality Controlunmatched
    • Quality Managementunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Submissionsunmatched
    • Relationship Managementunmatched
    • Research Protocolsunmatched
    • Site Initiationunmatched
    • Team Lead/Managerunmatched
    • Women's Healthunmatched

    Benefits

    Paid Sick Days, Prescription Drug Coverage, Professional Development, 401K, Flexible Spending Accounts, Tuition Reimbursement, Life Insurance

    About Company

    Wayne State University is a premier, public, urban research university located in the heart of Detroit where students from all backgrounds are offered a rich, high quality education. Our deep rooted commitment to excellence, collaboration, integrity, diversity and inclusion creates exceptional educational opportunities preparing students for success in a diverse, global society.

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