Regulatory Affairs Specialist I

Florida Cancer Specialists & Research Institute•Sarasota, FL

4d•Hybrid

About The Position

The Regulatory Affairs Specialist I supports clinical research compliance and study administration at Florida Cancer Specialists & Research Institute. The role creates and maintains regulatory files and study documentation in accordance with site standard operating procedures, federal regulations, ICH, and GCP guidelines, while protecting the confidentiality and security of patient records. It supports research staff and investigators with protocol-specific and GCP training, manages IRB submissions and approved documents, and helps ensure informed consent documentation and study enrollment records are complete and current. The specialist also coordinates monitoring visits, study termination and closeout activities, and preparation for internal and external audits. The role works with research coordinators, investigators, sponsors, monitors, and the Sarah Cannon Regulatory Department to address findings, resolve discrepancies, and maintain complete and accurate study records. The position is based at the Sarasota Cattlemen Office, with the ability to work remotely effectively as required and travel to satellite offices or offsite meetings as needed. Standard hours are Monday through Friday, 8:00 AM to 5:00 PM.

Requirements

High school education is required.
Valid state driver's license for travel to satellite offices and offsite meetings.
Compliance with the company Driver Safety Operations and Motor Vehicle Records Check Policy.
Critical thinking, problem-solving, analytical, decision-making, planning, time-management, and organizational skills.
Attention to detail and ability to exercise independent judgment.
Interpersonal effectiveness, diplomacy, tact, conflict-management skills, and ability to handle sensitive and confidential matters.
Good command of English and effective oral, written, and presentation communication skills.
Strong customer focus and ability to collaborate with stakeholders across the organization.
Ability to manage time, stress, and competing priorities; work independently with limited supervision; and work effectively in a fast-paced, multi-site environment.
Ability to work remotely effectively as required.
Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.

Nice To Haves

Bachelor’s degree in Biological Science, Social Sciences, English, or another related field.
Previous clinical research experience.
A second language.

Responsibilities

Create and maintain central regulatory files and study-specific documentation in physical regulatory binders and electronic document systems.
Maintain knowledge of FCS policies, federal regulations, ICH, and GCP guidelines, and protect patient records in accordance with HIPAA.
Maintain research delegation logs and role-specific profiles, study-specific FDA Form 1572s, financial disclosure forms, historical credentials, and laboratory licenses and certifications.
Support GCP and protocol-specific training by uploading and archiving training modules, assigning training, and maintaining training documentation.
Prepare and submit IRB materials and continuing review reports, obtain and file IRB approvals, amendments, and related correspondence, and ensure study documentation is maintained in the Regulatory Binder.
Support the process for reporting Serious Adverse Events to the IRB when reporting is required, as determined by the PI.
Notify research coordinators of newly approved or amended protocols and informed consent forms, and provide instructions for timely subject reconsenting.
Review signed informed consent forms for completeness, notify coordinators of discrepancies, maintain a log of consent versions, and maintain an electronic master subject/enrollment list for each study.
Prepare for and support interim monitoring visits, maintain the Site Visit Log, coordinate resolution of monitoring discrepancies, review monitoring reports, and ensure findings are addressed.
Schedule, prepare, and conduct study termination visits; ensure study records and electronic reporting systems are complete and finalized; and coordinate document submission and archiving.
Prepare for internal and external audits by retrieving documents and ensuring study-related records are complete.
Perform other duties and projects as assigned.