"Clinical Research HRPP Program Specialist"

Job Details

Title: Clinical Research HRPP Program Specialist

Department Org: Jacobson Clinical Research Center - 107980

Employee Classification: U1 - Unclassified PSA FT

Bargaining Unit: Professional Staff Association

Primary Location: MC AD

Shift: 1

Posted Salary: Salary will commensurate with experience

Job Description:

This role serves as a lead for monitoring regulations and guidance to identify and ensure implementation of changes to operational processes or best practices for clinical research. This position provides 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.

Minimum Qualifications:

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

Conditions of Employment:

To promote the highest levels of health and well-being, the University of Toledo campuses are tobacco-free. To further this effort, the University of Toledo Health Science Campus Medical Center is requiring candidates for employment to be nicotine-free. Pre-employment health screening requirements will include cotinine (nicotine) testing, as well as drug and other required health screenings for the position. With the exception of positions within University of Toledo Main Campus and the University of Toledo College of Medicine and Life Sciences, the employment offer is conditional upon successful completion of a cotinine test and Occupational Health clearance.