Clinical Data and Regulatory Compliance Specialist - Office of Women’s Health

Wayne State University • Detroit, MI

17d

About The Position

Wayne State University is searching for an experienced Clinical Data and Regulatory Compliance Specialist - Office of Women’s Health at its Detroit campus location. Wayne State is a premier, public, urban research university located in the heart of Detroit, Michigan 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 which prepare students for success in a global society. The Clinical Data and Regulatory Compliance Specialist, in Women's Health Research at the Office of Women’s Health (OWH), will provide strategic oversight of data governance, regulatory documentation, and compliance processes while supporting the development of internal procedures and training materials that strengthen long-term institutional capacity. This targeted expertise will facilitate efficient communication between the organization, research sites, sponsors, and regulatory bodies, ensuring that data integrity, participant protections, and documentation standards. This position reports to the Director, Regulatory and Compliance.

Requirements

• Master's degree from an accredited university or college in Health Sciences or Biomedical Sciences.
• Candidates are expected to have hands-on experience with GxP standards (Good “X” Practices), Institutional Review Board (IRB) submissions, documentation control, and regulatory audits and inspections.
• Experience working with data systems, quality processes, and cross-functional regulatory teams is also highly valued.
• Ability to work independently.
• Knowledge of and experience with IRB submissions and databases such as Medidata, OnCore, or similar databases.
• Excellent time management and organizational skills.
• Excellent interpersonal skills and demonstrated ability to work with others in a collaborative environment.

Responsibilities

• Review study protocols, case report forms (CRFs), and informed consent documents for regulatory and ethical compliance.
• Conduct audits and gap analyses of clinical trial documentation, data management systems, and site practices.
• Ensure compliance with all clinical research activities with FDA, EMA, ICH-GCP, and institutional regulatory requirements.
• Develop, implement, and monitor data governance and quality assurance procedures to maintain data integrity and accuracy.
• Support preparation and submission of regulatory filings (INDs, NDAs, CTAs, annual reports) and ethics committee materials.
• Collaborate with clinical operations, data management, and biostatistics teams to ensure compliant data handling and reporting.
• Provide training and guidance to research staff on regulatory standards, data protection, and documentation practices.
• Track and interpret updates to global and local regulatory guidelines, advising stakeholders on required process adjustments.
• Other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees