Regulatory Research Support Specialist (IRB & GCP)

The University of South Florida; Tampa (FL); Sur place; USD 48 000 - 60 000; Plein temps

Résumé du poste

The University of South Florida is seeking a Sr. Research Support Specialist - Regulatory in Tampa, FL. This role supports adherence to SOPs and regulatory requirements while building foundational expertise in human subject protections and GCP.

It is time limited and requires a Level II background check. The position emphasizes preparing IRB submissions, maintaining regulatory logs, and ensuring accurate credentialing and training documentation across study teams, with a focus on HIPAA

Qualifications

• This entry-level role requires a high school diploma with six years of office, administrative, or research support experience.
• A bachelor’s degree is preferred, or an equivalent combination of education and relevant experience.
• Experience with regulatory documentation and clinical research workflows is desirable.

Responsabilités

• Assist with the preparation and submission of IRB applications, amendments, continuing reviews, and closures.
• Upload and organize regulatory documents in Florence eBinders following SOPs and version control.
• Maintain tracking logs for training, delegation, protocol versions, and other regulatory records.
• Enter and update study-related regulatory activity in Velos CTMS to support documentation and billing.
• Ensure study team credentialing and training documentation are accurate and current.
• Assist with audit readiness and inspection preparation by maintaining 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.

Connaissances

Attention to detail

Regulatory compliance

Communication skills

Organization

Time management

Formation

High School Diploma

Bachelor's degree preferred

Outils

Florence eBinders

Velos CTMS

Microsoft Office

Description du poste

The University of South Florida is seeking a Sr. Research Support Specialist - Regulatory in Tampa, FL. This role supports adherence to SOPs and regulatory requirements while building foundational expertise in human subject protections and GCP.

It is time limited and requires a Level II background check. The position emphasizes preparing IRB submissions, maintaining regulatory logs, and ensuring accurate credentialing and training documentation across study teams, with a focus on HIPAA