Clinical Research Regulatory Specialist

Rovia Clinical Research

. Perform startup activities, including IRB submissions, regulatory documentation, vendor access, and training access .

Posted 11/2/2026full-timeRemote • United StatesJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory documentation and compliance within clinical research, including proficiency in ICH/GCP guidelines and FDA regulations. Strong organizational and communication skills are essential for effective collaboration with investigators and research staff.

Highest-signal resume keywords

Clinical Research ExperienceRegulatory Documentation ManagementGCP CertificationKnowledge of ICH/GCPProficient in Microsoft Office

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory DocumentationQuality AssuranceMedical TerminologyFinancial Disclosure FormsFDA 1572Investigative Brochure Signature PagesDelegation of Authority LogsInvestigator CV CreationSite Selection VisitsContinuing Reviews

Soft Skills

Interpersonal SkillsAttention to DetailConfidentiality MaintenanceWritten CommunicationOrganizational Skills

Tools & Technologies

Florence eRegulatory PlatformMicrosoft ExcelAdobe Acrobat

Certifications & Qualifications

GCP CertificationLicense/Certification Status with CEUs

Industry Keywords

IRB SubmissionsRegulatory RequirementsFDA PoliciesHIPAA PoliciesSOP Development

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Perform startup activities, including IRB submissions, regulatory documentation, vendor access, and training access
Assist with management of Rovia’s Florence eRegulatory platform, including creating study binders, filing startup and maintenance documents, performing quality checks, and monitoring investigator and site credentials
Complete regulatory documentation such as Financial Disclosure Forms, Protocol Signature Pages, FDA 1572s, and Investigative Brochure Signature Pages
Route regulatory documents to research staff and investigators for signatures and follow up as needed
Collaborate with investigators and research staff to complete outstanding documents
Return regulatory documents and credentials to sponsors/CROs in a timely manner
Create and update delegation of authority logs throughout study duration
Create training logs
Review Investigator Site Files for completion and accuracy
Gather documents requested during Site Selection Visits
Create investigator CVs and update them biannually or as requested
Obtain and maintain valid medical licenses for investigators
Participate in development of company SOPs and Guidance Documents
Create and submit continuing reviews, protocol deviations, and other ongoing IRB submissions
Perform other job-related duties as requested or required

Requirements

What you’ll need

High school diploma required
Bachelor’s degree preferred
1–2 years of clinical research experience with an emphasis in regulatory and QA
License/certification status with CEUs, as applicable
Current GCP certification
Sound knowledge of medical terminology
Sound knowledge of ICH/GCP, regulatory requirements, FDA and HIPAA policies and practices
Excellent interpersonal skills to interact effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors, and sponsors
Meticulous attention to detail
Ability to maintain confidentiality
Strong written communication skills
Strong organizational skills
Proficient in Microsoft Office, Microsoft Excel, and Adobe Acrobat
Ability to meet multiple and changing deadlines
Ability to consult numerous sources for information to prepare documents
Fluent in spoken and written English

Benefits

Comp & perks

Supported, valued workplace
Career growth opportunities
Collaborative team environment