Sr. Research Support Specialist - Regulatory

About the role

This entry-level role ensures adherence to institutional SOPs and applicable regulations while developing foundational expertise in human subject protections and Good Clinical Practice (GCP).

Responsibilities

• Assist with the preparation and submission of IRB applications, amendments, continuing reviews, and closures.
• Upload and organize regulatory documents in Florence eBinders (eISF) following institutional SOPs and version control requirements.
• Maintain tracking logs for training, delegation, protocol versions, and other required regulatory documentation.
• Enter and update study-related regulatory activity in Velos (CTMS) to support documentation and billing.
• Absorb study team credentialing and training documentation to ensure accuracy and currency.
• Aid in audit readiness and inspection preparation by maintaining organized and compliant eBinders.
• Support communication with IRBs, sponsors, and internal stakeholders regarding documentation and updates.
• Ensure protection of confidential data in accordance with HIPAA and institutional standards.
• Participate in team training, internal process reviews, and quality improvement efforts.
• Perform other duties as assigned by supervisor or leadership.

Qualifications

• Minimum Qualifications: High school diploma or equivalent and six years of experience in office or administrative support or in research support. College education may be substituted for the required experience on a year for year basis.
• Preferred Qualifications: Bachelor's degree in a scientific, health-related, or business field, OR equivalent combination of education and relevant experience. Experience with Microsoft Office (Word, Excel, Outlook) required. Experience in research administration, IRB submission, or regulatory documentation. Familiarity with Florence eBinders, Velos CTMS, or other regulatory platforms. Understanding of clinical research protections, HIPAA, and GCP guidelines.

About Us

Working at USF With approximately 16,000 employees, the University of South Florida is one of the largest employers in the Tampa Bay area. We are dedicated to cultivating a talented, engaged and driven workforce that strives to be bold. Employees excel in USF‘s rich academic environment, which fosters their development and advancement. In 2025, Forbes recognized USF as one of Florida’s best large employers, ranked No. 1 among the state’s 12 public universities. Our first-class benefits package includes medical, dental and life insurance plans, retirement plan options, employee and dependent tuition programs, generous leave, and hundreds of employee perks and discounts.

Compliance and Federal Notices

This position may be subject to a Level 1 or Level 2 criminal background check. Applicants for USF employment are entitled to request reasonable accommodation(s) in the application process. A request is to be made at least five (5) working days prior to the time the accommodation(s) is needed. Visit the Central Human Resources ADA Accommodations webpage for more information on requesting an accommodation during the application/interview process.