Research Regulatory Specialist

Summary

Participates as a member of a multi-disciplinary team in the conduct of clinical research trials and collection of subject data and clinical samples and documentation which includes identifying potential participants, screening of potential participants for eligibility, consenting of participants, conducting interviews with participants, medical testing, and maintaining applicable databases.  Work is performed under general supervision by the principal investigator of the research unit.

Examples of Work

Job functions are specific duties that would be included in the essential functions of the job description.  These functions are not all-inclusive nor do they cover the full extent of the duties performed.

• Submits serious adverse events, Investigational New Drug (IND) reports, protocol addenda and/or other documents to Institutional Review Boards in accordance with prescribed procedures.
• Prepares Institutional Review Board continuing review reports in accordance with prescribed procedures.
• Maintains and updates IRB tracking database; perform quality assurance reviews of the tracking database; maintains up-to-date comprehensive regulatory and/or study binders; maintains protocols, consents and Institutional Review Board documents.
• Assists Research Administrators with clinical research trials by collecting protocol-required data from medical records, entering data on case report forms or into a computerized database, and maintaining case report forms in compliance with privacy laws.
• Coordinates the procurement of human blood samples, body fluid samples, and/or tissue samples that are collected for research purposes.
• Assists Study Coordinators with the conduct of therapeutic clinical research trials.
• Provides sponsors with updated regulatory documents; performs regular quality assurance reviews of local and remote working files.
• Develops and implements of research team procedures, and assigns duties to staff and students to support the overall mission of the research team.
• Assists in the interpretation and implementation of federal, state, and University of Florida policies and procedures as they apply to the clinical research activities.
• Plans, schedules, and coordinates research team meetings that are needed to facilitate communication about and coordination of research activities.
• Supports financial aspects related to grants and contracts, such as participant remuneration, distribution of bills and invoices, monitoring monthly budget expenses, and ensures that proper procedures related to financial aspects are followed.
• Interacts with laboratories involved with research activity to ensure adherence to clinical protocols and to meet regulatory requirements.
• Facilitates collaboration with new investigators and students from a variety of disciplines; assists with recruitment and data collection from cohort participants.
• Identifies potential participants for the studies screens potential participants for eligibility, obtains consent of participants, conducts interviews with participants, performs medical tests required by study parameters, and maintains databases for studies.
• Works with study teams to develop new objectives, goals, and performance measures for the study; works closely with study teams to ensure that the study direction is implemented timely and effectively.
• Actively participates in designing new interventions, analyzing the effectiveness of the program and the outcomes, and proposing innovative directions for the program.

Education and Experience

Bachelor’s degree and two years of appropriate experience; or an equivalent combination of education and experience.

Licensure and Certification

N/A

Supervision

This position may include supervisory responsibility.

To see common career pathways for each position at the University of Florida please visit the Career Paths section of the UFHR website.