Regulatory Affairs Specialist I

Florida Cancer Specialists & Research Institute

. Create and maintain central regulatory files according to site SOPs .

Posted 11/6/2026full-timeSarasota • Florida • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory compliance, including GCP, ICH guidelines, and HIPAA regulations, while effectively managing study-specific documentation and maintaining investigator credentials. Exhibits strong organizational, analytical, and communication skills to support clinical research activities and ensure adherence to protocols.

Highest-signal resume keywords

Regulatory ComplianceGCP GuidelinesClinical Research ExperienceDocumentation ManagementEffective Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory DocumentationIRB SubmissionALCOAC MethodFDA Form 1572Study Closeout ProceduresMonitoring ActivitiesConflict ManagementCritical ThinkingTime ManagementDetail-Oriented

Soft Skills

Interpersonal SkillsEmotional IntelligenceProblem SolvingOrganizational SkillsIndependent Judgment

Tools & Technologies

MS Office WordMS Office ExcelMS Office PowerPointMS Office Outlook

Certifications & Qualifications

Valid State Driver's LicenseRequired Vaccinations

Industry Keywords

Clinical ResearchHIPAA ComplianceFCS PoliciesSite SOPsLaboratory LicensesCLIA DocumentationMonitoring FindingsStudy Termination VisitsDiversity AwarenessFast-Paced Environment

About the role

Key responsibilities & impact

Create and maintain central regulatory files according to site SOPs
Maintain knowledge of FCS policies, federal regulations, ICH, and GCP guidelines
Protect the confidentiality and security of patient records under HIPAA
Collect and maintain study-specific regulatory documentation and electronic records
Create and maintain delegation of authority logs, role-specific profiles, FDA Form 1572, and financial disclosure forms
Maintain investigator and research staff credentials, laboratory licenses, and CLIA/COLA documentation
Maintain credible documentation using the ALCOAC method
Support GCP and protocol-specific training by assigning, uploading, archiving, and documenting training
Prepare and submit IRB documents, continuing reviews, amendments, revised informed consents, protocols, and SAE reports
Maintain IRB approval documentation, consent-version logs, and master subject/enrollment lists
Notify research coordinators of IRB-approved protocol or informed-consent changes
Review signed informed-consent forms for completeness and resolve discrepancies
Prepare for and conduct on-site and remote monitoring activities and interim monitoring visits
Collaborate with Sarah Cannon Regulatory Department and sponsor representatives to resolve monitoring findings
Maintain site visit logs and monitoring correspondence
Schedule, prepare, and conduct study termination visits
Complete study closeout, electronic final signatures, document submission, query resolution, packaging, and archiving
Prepare for internal and external audits
Perform other assigned duties and projects

Requirements

What you’ll need

High school education required
Bachelor’s degree in Biological Science, Social Sciences, English, or other related field preferred
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
Prior clinical research experience preferred but not required
Critical thinking, problem solving, analysis, decision-making, planning, time management, and organizational skills
Detail-oriented with ability to exercise independent judgment
Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness
Ability to work effectively with sensitive and confidential material and emotionally charged matters
Good command of the English language
Effective oral, written, and presentation communication skills
Ability to work independently with limited supervision
Ability to work remotely effectively as required
Ability to work effectively in a fast-paced, multi-site environment and manage competing priorities
Proficiency in MS Office Word, Excel, PowerPoint, and Outlook
Ability to travel to satellite offices and offsite meetings
Successful background and drug screens
Required vaccinations, including influenza vaccine, barring an approved exemption

Benefits

Comp & perks

Competitive wages
Tuition reimbursement
401-K match
Pet insurance
Legal insurance
Professional opportunities
Career advancement
Training
Comprehensive benefits packages
Influenza vaccination requirement with approved exemption process