Clinical Research HRPP Program Specialist

Roles & Responsibilities
• Monitor clinical research regulations and guidance to identify and implement changes in operational processes
• Provide expert advice to Principal Investigators, Clinical Research Coordinators, and research personnel on compliance requirements
• Ensure regulatory and ethical compliance across the full lifecycle of clinical research and trials
• Conduct ongoing education and training programs for clinical research staff
• Perform on-site monitoring for industry-funded and investigator-initiated clinical studies
• Develop, review, and maintain Standard Operating Procedures (SOPs) and training documents
• Ensure adherence to Good Clinical Practice (GCP), FDA regulations, and applicable guidelines
• Support compliance oversight related to grants, contracts, and institutional research practices

Qualification
• Bachelor’s degree in Nursing, Public Health, Healthcare, Clinical Research, or related discipline

Experience
• Minimum 4+ years of professional experience in academic or regulatory clinical research settings
• Experience managing or training clinical research personnel
• Exposure to academic medical center research practices

Skills
• Strong knowledge of GCP, FDA regulations, and clinical research compliance
• Understanding of Medicare Coverage Analysis, Fair Market Value, and Standard of Care
• Familiarity with medical coding, medical terminology, and electronic health information systems
• Proficiency in Microsoft Office applications
• Strong problem-solving and analytical skills
• Ability to interpret and apply federal and non-federal regulations for grant and contract management

About the Company
The University of Toledo is a comprehensive public research university committed to advancing education, research, and healthcare innovation. Through its strong clinical research and compliance frameworks, the university supports ethical, high-quality research while fostering diversity, inclusion, and equal opportunity across its academic and research communities.