Regulatory Specialist I

Moffitt Cancer Center

2d•$24 - $36

About The Position

The Regulatory Specialist I supports research activities by completing protocol-specific documents and standardized reports to ensure effective, compliant protocol activity from activation through closure. The role focuses on completing, submitting, filing, and reporting regulatory documents in accordance with Moffitt and IRB policies, sponsor requirements, and federal regulations for research involving human subjects. The specialist is trained to distinguish among compassionate use, emergent use, humanitarian device, biomedical, and social science studies so the appropriate IRB application can be filed. Working with a manager or mentor as needed, the specialist processes regulatory applications and submissions throughout a study’s lifecycle, maintains electronic study records, supports audits, and serves as a liaison between internal and external stakeholders.

Requirements

High school diploma or GED required.
High school diploma or GED with at least 3 years of relevant experience, or an associate degree with at least 2 years of relevant experience; a bachelor’s or master’s degree may substitute for relevant experience.
Thorough knowledge of word processing and database usage required.

Responsibilities

Review and extract required information from protocols, investigator’s brochures, and other source documents to complete applications, including drafting informed consent documents using model language and applicable Moffitt or IRB terminology.
Provide draft consent documents to sponsors for approval.
Process BioSafety applications alongside IRB applications and complete OBA requirements as necessary, with guidance from a manager or mentor.
Collaborate with research teams and sponsors to obtain scientific and clinical information needed to complete applications.
File HIPAA and consent waivers through the IRB when applicable.
Submit application documents and applicable addenda to the appropriate IRB.
Process Form 1572 and financial disclosures.
File electronic copies in ebinders according to CTO standards.
Provide sponsors with regulatory startup information, including research staff credentialing and Moffitt certifications.
Reconcile IRB queries to ensure study approval.
Distribute approval documents to relevant stakeholders.
Process and submit IRB modifications and amendments documenting study changes.
Process and submit IRB information reports for protocol deviations, exceptions, and other matters requiring acceptance rather than approval.
Process and submit progress reports and related addenda within specified timeframes to support study continuation.
Complete final reviews for formal study termination to ensure regulatory compliance.
Run OnCore reports and research data to process IRB forms.
File correspondence electronically for future retrieval and upload IRB approvals to ebinders and OnCore.
Serve as a study liaison between internal and external customers by answering queries, providing documentation, and processing requests.
Gather documentation for internal and external audits in collaboration with research staff and draft regulatory responses.
Track workload in Excel and file weekly in the CTO drive using approved CTO tracking logs.