Regulatory Affairs Specialist I-III

University of Arkansas System

. Ensure regulatory compliance and administrative management for multiple clinical trials .

Posted 10/9/2026full-timeLittle Rock • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory compliance and administrative management for clinical trials, with a strong focus on oncology and clinical research. Proficient in developing and managing research protocols, documentation, and electronic infrastructure for clinical trial management.

Highest-signal resume keywords

Regulatory ComplianceClinical Trial ManagementOncology ExperienceRAC CertificationStudy Planning and Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchProtocol DevelopmentData AnalysisAdverse Event ReportingDocument PreparationStudy Proposal ReviewRegulatory Document ManagementWorkflow MaintenanceQuality Standards AdherenceConsent Form Generation

Soft Skills

CollaborationAdvisory SkillsCommunication

Tools & Technologies

Clinical Trial Management SystemsElectronic Infrastructure

Certifications & Qualifications

RACCCRPCCRCCRS Certification

Industry Keywords

Clinical TrialsOncologyIRB ComplianceNCI CIRBFederal RegulationsResearch ProtocolsStudy ActivationStudy CloseoutInvestigator BrochuresConsent Forms

About the role

Key responsibilities & impact

Ensure regulatory compliance and administrative management for multiple clinical trials
Work closely with investigators, industry sponsors, contract research organization representatives, and UAMS institutional oversight offices
Apply local policies, federal regulations, and guidelines to an assigned clinical trial portfolio
Contribute to cross-functional teams and maintain workflow and quality standards
Advise PIs on administrative and regulatory requirements for clinical studies and study proposals
Monitor and facilitate study/proposal review and approval processes
Coordinate with NCI CIRB for cooperative group protocol approvals
Participate in development of electronic infrastructure and clinical trial management systems
Maintain protocol amendments, revisions, memos, consent-form changes, investigator brochures, advertisements, and study closures
Generate consent forms compliant with UAMS, IRB, and federal requirements
Prepare written documents, analyze data, and formulate conclusions
Develop, prepare, and submit research protocols and documentation to campus oversight committees
Process adverse event and death reports within sponsor and IRB timelines
Schedule Site Initiation and Monitoring Visits
Review proposals for compliance with sponsor formatting guidelines
Monitor protocol status and advise PIs on requirements and deadlines
Create and manage regulatory study binders and maintain regulatory documents
Level III specialists may lead special projects or act in the Regulatory Team Manager’s absence

Requirements

What you’ll need

Level I: Bachelor's degree plus 3 years of general research experience, or High School, GED, or formal education equivalent plus 7 years of research experience in lieu of a bachelor’s degree
Level II: Bachelor's degree plus 3–5 years of general research experience with demonstrated experience/proficiency in specified oncology clinical-trial functional areas, or High School, GED, or formal education equivalent plus 7 years of research experience in lieu of a bachelor’s degree and study planning/development, regulatory and/or financial start-up, regulatory maintenance and reporting from study activation to closeout
Level III: Bachelor’s Degree plus 5 years clinical research experience with demonstrated experience/proficiency in all specified key functional areas
Level III must possess RAC, CCRP, CCRC, or equivalent certification at time of hire
Obtain CRS certification within 2 years of hire for all levels
Oncology experience preferred
Clinical Research experience preferred
Proof of legal authority to work in the United States on the first day of employment
Pre-employment screening may include criminal background, drug testing, and/or education verification
Required documents: list of three professional references and resume

Benefits

Comp & perks

Medical, Dental and Vision plans available for qualifying staff and family
Holiday, Vacation and Sick Leave
Education discount for staff and dependents (undergraduate only)
Up to 10% matched contribution from UAMS
Basic Life Insurance up to $50,000
Career Training and Educational Opportunities
Merchant Discounts
Concierge prescription delivery on the main campus when using UAMS pharmacy