Clinical Research HRPP Program Specialist

University of Toledo has proudly served our community since 1872. We offer competitive wages, access to the Public Employees Retirement System, generous time off allowances and additional wellness benefits. As part of the University of Toledo, employees and their dependents also have access to education benefits at UToledo. Job Information Job no: 500310 Work type: Staff - Full-Time Location: Health Science Campus College, Toledo, OH Categories: Administration, Healthcare Positions, Hospital Administration, Full-Time, Research, None, Academic, Administrative Support 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. The 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 adhere to Good Clinical Practice (GCPs) and all applicable regulations. Minimum Qualifications Requires Bachelor’s degree in nursing, public health, healthcare, clinical research, or a related discipline. Minimum of four (4) years of demonstrated professional and functionally relevant experience in an academic or regulatory setting as well as clinical research and trials, including 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. The University of Toledo Health Science Campus Medical Center requires candidates for employment to be nicotine‑free. Pre‑employment health screening will include cotinine (nicotine) testing, as well as drug and other required health screenings. 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. Equal Employment Opportunity Statement The University of Toledo is an equal opportunity employer. The University of Toledo does not discriminate in employment, educational programs, or activities on the basis of race, color, religion, sex, age, ancestry, national origin, sexual orientation, gender identity and expression, military or veteran status, disability, familial status, or political affiliation. Contact Human Resources Department: View phone number on click.appcast.io View email address on click.appcast.io #J-18808-Ljbffr