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The University of Toledo · 3 weeks ago

Clinical Research HRPP Program Specialist - 500310

Toledo, OH

Full-time

Onsite

Mid Level

4+ years exp

The University of Toledo is seeking a Clinical Research HRPP Program Specialist to lead the monitoring of regulations and ensure compliance in clinical research processes. This role involves providing expert advice, ongoing education, and quality management duties related to clinical research studies within the institution.

Health CareMedicalPersonal Health

Responsibilities

Serve as a lead for monitoring regulations and guidance to identify and ensure implementation of changes to operational processes or best practices for clinical research

Provide expert advice to principal investigators (PIs), Clinical Research Coordinators, leadership and other ORSP personnel involved in ensuring compliance throughout the lifecycle of clinical research and trials

Responsible for the ongoing education and training of clinical research personnel and on-site clinical research monitoring of industry funded and investigator-initiated clinical research studies within the institution

Quality management duties include development and ongoing review of standard operating procedures (SOPs) and training documents for new coordinators that adheres to Good Clinical Practice (GCPs) and all applicable regulations

Qualification

Clinical research experienceClinical Practice (GCP)FDA regulations knowledgeElectronic health systemsMedical coding knowledgeTraining personnelMicrosoft Office proficiencyGrant management regulationsProblem-solving ability

Required

Requires Bachelor's in nursing, public health, healthcare, clinical research, or a related discipline

Minimum of four (4) years demonstrated professional and functionally relevant experience in an academic or regulatory setting as well as clinical research and trials. Including, but not limited to, human subject research, research processes, and compliance with appropriate regulations

Demonstrated experience in direct or indirect management or training of personnel

Knowledge of academic medical center standard practices and policies, including but not limited to Medicare Coverage Analysis, Fair Market Value and Standard of Care

Working knowledge of FDA and Good Clinical Practice guidelines and regulations

Understanding of medical coding and knowledge of medical terminology

Proficient in electronic health information systems (i.e., EPIC), Microsoft Office suite, and ability to learn and use other software systems as required by the position

Ability to define problems, collect data, establish facts, and draw valid conclusions

Background with federal and non-federal regulations for grant and contract management