Clinical Research HRPP Program Specialist - 500310

UToledo Current Employee • Toledo, OH

20d

About The Position

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.

Requirements

• 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

Responsibilities

• Monitoring regulations and guidance to identify and ensure implementation of changes to operational processes or best practices for clinical research.
• Providing 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.
• Ongoing education and training of clinical research personnel
• On-site clinical research monitoring of industry funded and investigator-initiated clinical research studies within the institution.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees