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Wayne State University · 1 day ago

Clinical Data and Regulatory Compliance Specialist - Office of Womens Health

Detroit, MI

Full-time

Onsite

Senior Level

$62K/yr - $74K/yr

7+ years exp

Wayne State University is a premier public urban research university located in Detroit, Michigan, seeking an experienced Clinical Data and Regulatory Compliance Specialist for its Office of Women's Health. The role involves ensuring compliance with regulatory standards, conducting audits, and providing strategic oversight of data governance and compliance processes.

Higher Education

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

Qualification

GxP standardsIRB submissionsRegulatory auditsData governanceMedidataOnCoreQuality processesTime managementInterpersonal skillsCollaborative environment

Required

Master's degree from an accredited university or college in Health Sciences or Biomedical Sciences

7+ years experience as an established subject matter expert

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

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