[Hiring] Regulatory Specialist I @Moffitt Cancer Center

Role Description

To support research activities through the completion of protocol specific documents and standardized reports for effective and compliant protocol activity from activation through closure. The primary focus is on regulatory document completion, submission, proper filing and reporting to achieve and maintain compliance with internal policy (Moffitt) IRBs, external sponsor and federal regulations pertinent to research involving human subjects.

Qualifications

• High School Diploma/GED required.
• HSD with 3 or more years of relevant experience or Associate's degree with 2 or more years of relevant experience. BS or MS degree may substitute the relevant experience.
• Thorough knowledge of word processing and database usage required.

Requirements

• Assist to review and extract all required data from the protocol, investigator’s brochure, and any other pertinent source documentation to complete the application process to include drafting the informed consent by combining model consent language with Moffitt/Respective IRB’s terminology.
• Provide draft consents to the respective sponsor for approval.
• With either manager or mentor, Reg. Spec I will process BioSafety applications in conjunction with IRB applications and complete OBA requirements as necessary.
• Collaborate with the respective research team/sponsor for scientific/clinical information required for application completion.
• File HIPAA/Consent waivers when applicable through the IRB.
• Submit application documents along with appropriate addenda to the respective IRB.
• Process the 1572 and financial disclosures.
• File all electronic copies in ebinders according to CTO standards.
• Provide Regulatory start up information to the respective sponsors to include credentialing for each research staff member as well as Moffitt’s certifications.
• Reconcile all IRB queries to ensure study approval.
• Provide approval documents to respective stakeholders.
• Process and submit modifications/amendments to the IRB documenting any study changes.
• Process and submit information reports to the IRB documenting any protocol deviations, exceptions, and/or other information that only requires IRB acceptance rather than approval.
• Process and submit progress reports along with respective addenda within the specified timeframe to ensure study continuation.
• Process final reviews for formal study termination to ensure regulatory compliance.
• Run OnCore reports and research data to process IRB forms.
• Electronically file all correspondence for future retrieval and upload all IRB approvals to ebinders and OnCore accordingly.
• Act as a study liaison between internal and external customers answering queries, providing documentation, processing requests, etc.
• Gather required documentation for internal/external audits collaborating with the research staff and draft regulatory responses.
• Track workload in Excel and file weekly in the CTO drive using approved CTO tracking logs.

Benefits

• Salary Range: $23.90 - $36.41
• We are committed to maintaining fair and equitable pay practices and regularly review compensation to ensure alignment across our workforce.