Title: Clinical Research HRPP Program Specialist

Department Org: Research & Sponsored Programs - 107920

Employee Classification: U1 - Unclassified PSA FT

Bargaining Unit: Professional Staff Association

Primary Location: MC AD

Shift:  1

Posted Salary: Salary will commensurate with education and 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:

Equal Employment Opportunity Statement:

The University of Toledo is an equal opportunity, affirmative action 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. 

The University is dedicated to the goal of building a culturally diverse and pluralistic faculty and staff committed to teaching and working in a multicultural environment and strongly encourages applications from women, minorities, individuals with disabilities, dual-career professionals and covered veterans.

The University of Toledo provides reasonable accommodation to individuals with disabilities. If you require accommodation to complete this application, or for testing or interviewing, please contact the HR Compliance at  hrcompliance@utoledo.edu or 419-530-4747 between the hours of 8:30AM and 5:00PM or apply online for an accommodation request. 

Computer access is available at most public libraries and at the Office of Human Resources located in the Center for Administrative Support on the Main Campus of the University of Toledo.