Regulatory Affairs Specialist I

Florida Cancer Specialists•Bradenton, FL

3d•Onsite

About The Position

The Regulatory Affairs Specialist I creates and maintains central regulatory files in accordance with site standard operating procedures (SOPs), while adhering to FCS policies and applicable federal regulations, ICH, GCP, and HIPAA requirements. The role maintains study-specific documentation in regulatory binders and electronic systems, supports staff and investigator training, and ensures confidential patient information is protected. The specialist prepares and tracks IRB submissions and approvals, maintains records of approved study documents and consent versions, supports SAE reporting processes, and communicates approved protocol or consent changes to research coordinators. The role also manages monitoring, audit, study termination, closeout, and archiving activities, working with research staff, sponsors, monitors, and the Sarah Cannon Regulatory Department to resolve issues and ensure complete study records. Other duties and projects may be assigned. This position is based at the Sarasota Cattlemen Office and may require travel to satellite offices and offsite meetings. Standard workdays are Monday through Friday, 8:00 AM to 5:00 PM. The position requires effectiveness in a fast-paced, multi-site environment and the ability to work remotely as needed.

Requirements

High school education required.
Valid state driver's license for travel to satellite offices and offsite meetings, and compliance with the company Driver Safety Operations and Motor Vehicle Records Check Policy.
Strong critical thinking, problem-solving, analysis, decision-making, planning, time management, organizational, and independent judgment skills.
Interpersonal effectiveness, emotional intelligence, diplomacy, tact, conflict management, delegation, and diversity awareness.
Ability to handle sensitive and confidential material and sometimes emotionally charged matters.
Good command of English and effective oral, written, and presentation communication skills; active listening and balanced feedback skills.
Strong customer focus and ability to collaborate and build effective relationships with employees, physicians, and the community.
Ability to manage time, conflicting priorities, stress, and professional development; self-motivated and able to work independently with limited supervision.
Ability to work remotely effectively as required and manage competing priorities in a fast-paced, multi-site environment.
Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.

Nice To Haves

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

Responsibilities

Maintain central regulatory files in accordance with site SOPs and keep working knowledge of FCS policies, federal regulations, ICH, and GCP guidelines.
Protect the confidentiality and security of patient records in accordance with HIPAA.
Collect and maintain study documentation in regulatory binders and electronic document systems.
Create and maintain research delegation-of-authority logs and role-specific profiles, updating them as roles and responsibilities change.
Create and maintain study-specific FDA Form 1572 documents and reconcile and update them as needed.
Collect and maintain investigator Financial Disclosure Forms and escalate reported disclosures to leadership.
Maintain historical credentials for investigators and research staff, as well as laboratory licenses and CLIA/COLA documentation, for Sponsor/CRO review as needed.
Maintain credible documentation using the ALCOAC method.
Support GCP and protocol-specific training by uploading and archiving training modules, assigning them according to site SOP, and maintaining training records.
Prepare and submit timely IRB reports and documents in accordance with site SOPs and federal regulations.
Obtain and maintain IRB approvals, amendments, revised informed consents, protocols, and related correspondence in regulatory binders.
Complete and submit IRB continuing review reports and file associated correspondence.
Ensure the process for reporting Serious Adverse Events to the IRB is followed when reporting is required, as determined by the PI.
Notify research coordinators by email when amended or new protocols or informed consent forms are IRB approved, and provide timely reconsent instructions.
Review signed informed consent forms for completeness and notify research coordinators of discrepancies.
Maintain an internal log of consent versions and an electronic master subject/enrollment list for each study through termination and archiving.
Prepare for interim monitoring visits by ensuring regulatory binders are complete, and work with the Sarah Cannon Regulatory Department to correct discrepancies.
Meet with Sponsor representatives as needed, maintain the Site Visit Log, and ensure monitors complete it before departure.
Review monitoring reports and letters, forward them to appropriate staff, track resolution of issues, and retain copies in regulatory binders.
Schedule, prepare, and conduct Study Termination Visits; ensure documents are filed, discrepancies are addressed in a NTF, required documents are sent to Sarah Cannon, and electronic documents and reporting systems are final signed.
Package and archive study files after closure and resolution of queries.
Prepare for internal and external audits by retrieving documents and ensuring study records are complete.
Perform other duties and projects as assigned.