REGULATORY SPECIALIST II

Moffitt Cancer Center

9d•$60,424 - $92,102

About The Position

The Regulatory Specialist II supports research regulatory activities by evaluating and completing protocol-specific documents and standardized reports. The role supports compliant protocol activity from activation through closure, with a focus on regulatory document preparation, submission, filing, and reporting in accordance with internal policies, sponsor requirements, state statutes, and federal regulations for human-subjects research. The specialist independently manages regulatory requirements and submissions for assigned programs, prepares and maintains informed consent forms and IRB/IBC applications, and processes Biosafety Committee applications alongside IRB submissions. The role serves as a central contact for regulatory queries and the primary liaison for protocol regulatory support, maintaining communication with internal and external customers and providing study teams with progress updates. It also supports audits, keeps study documents and regulatory files audit-ready, and provides mentoring and training to new regulatory staff and research team members.

Requirements

High school diploma or GED and at least 4 years of clinical research regulatory experience, preferably in oncology; or an associate or bachelor's degree and 2 years of clinical research regulatory experience, preferably in oncology; or a master's degree and 1 year of clinical research regulatory experience, preferably in oncology.

Nice To Haves

Two years of clinical research regulatory experience, including study activation.
Two years of experience in oncology.

Responsibilities

Independently prioritize and critically evaluate study-specific regulatory requirements and submissions for assigned programs.
Distinguish among compassionate use, emergent use, humanitarian device, biomedical, and social science studies to determine the appropriate IRB application.
Provide Study Startup and/or Maintenance coverage to disease programs as requested by management.
Create, maintain, and update informed consent forms and IRB/IBC applications.
Review and extract required information from protocols, investigator brochures, and other source documents to complete applications, including drafting informed consent forms using model language and institutional and IRB terminology.
Independently process Biosafety Committee applications in conjunction with IRB applications.
Mentor and train new regulatory staff and other research team members.
Serve as the central contact for regulatory queries, documentation, and processing requests.
Serve as the primary liaison for protocol regulatory support and communicate with internal and external customers, including providing regular progress updates to study teams.
Collaborate with research staff on internal and external audits, gather required documentation, and draft regulatory responses.
Help ensure study documents, SOPs, and regulatory files are maintained in audit-ready condition.