Regulatory Specialist I
Category: Regulatory Affairs / Clinical Research
Employment Type: Full-Time
Work Model: Onsite
Job ID: 2026-3303
Company: Velocity Clinical Research
Regulatory Specialist I Jobs in Clinical Research | Onsite Opportunity
Velocity Clinical Research, a fully integrated and owned research site organization, is hiring a Regulatory Specialist I to support clinical trial regulatory documentation and compliance activities. This full-time onsite role is ideal for early-career regulatory professionals seeking hands-on experience in IRB submissions, study start-up processes, and regulatory binder management within a high-performing clinical research environment.
Velocity is committed to accelerating clinical trials while delivering high-quality data and exceptional patient care. This position plays a critical role in ensuring regulatory readiness, compliance with ICH-GCP and FDA guidelines, and audit preparedness across clinical research studies.
Position Summary
The Regulatory Specialist I is responsible for preparing, maintaining, and submitting complete and accurate regulatory documentation to Institutional Review Boards (IRBs), sponsors, and regulatory authorities. The role supports clinical study start-up, ongoing compliance management, amendment processing, safety reporting, and close-out documentation.
This position requires strong attention to detail, knowledge of clinical research regulatory frameworks, and the ability to manage multiple deadlines in a fast-paced research environment.
Key Responsibilities
Regulatory Submissions & Study Start-Up
Prepare study-specific protocols, informed consent forms (ICFs), HIPAA authorizations, and related regulatory documents for IRB review
Support initial regulatory submissions to IRBs and sponsors to ensure site readiness metrics are met
Ensure timely submission of regulatory documents to prevent delays in study activation
Prepare and submit protocol amendments, continuing reviews, deviations, adverse event reports, and audit documentation
Regulatory Documentation & Compliance
Maintain and update regulatory binders (paper or electronic) to ensure continuous audit readiness
Maintain Delegation of Authority (DOA) logs and required regulatory logs
Submit or support SAE and AE reporting to IRBs within required timelines
Provide IRB documentation to sponsors as needed
Ensure compliance with ICH-GCP, FDA regulations, and applicable regulatory requirements
Training & Staff Support
Assist new hires in completing required research documentation and training
Track staff training status and notify leadership of upcoming expiration dates
Ensure all personnel listed on DOA logs have appropriate training documentation on file
Support financial disclosure documentation for study staff
Audit & Inspection Readiness
Conduct quality checks of regulatory binders prior to monitoring visits and audits
Assist in preparation for sponsor audits, monitoring visits, and regulatory inspections
Support study close-out activities, including submission of final documentation and archival of regulatory files
Additional Duties
Adhere to company safety and compliance policies
Support site leadership and coordinators as required
Perform additional regulatory tasks as assigned
Experience Requirements
Candidates must meet one of the following minimum experience criteria:
Bachelor’s degree with minimum 1 year of relevant experience in the life sciences or clinical research industry, OR
Associate’s degree with minimum 2 years of relevant experience in clinical research or regulatory support, OR
High school diploma or technical degree with minimum 3 years of relevant experience in the life sciences industry
Experience in clinical trial documentation, IRB submissions, regulatory binder management, or research site operations is strongly preferred.
Required Knowledge & Skills
Demonstrated understanding of ICH-GCP guidelines, FDA regulations, and regulatory compliance standards
Knowledge of medical terminology
Proficiency in Microsoft Office (Word, Excel, Outlook) and standard office technology
Strong written and verbal communication skills in English
Excellent organizational and documentation skills
Ability to multitask and prioritize in a deadline-driven environment
Strong attention to detail and quality control mindset
Ability to work independently with guidance and collaborate within cross-functional teams
Professional accountability and adaptability in a clinical setting
Physical & Work Requirements
Ability to sit or stand for extended periods
Limited walking and lifting (up to 30 pounds)
Ability to communicate effectively in person and via telephone
Occasional local or national travel may be required
Compensation & Benefits
Velocity Clinical Research offers a competitive benefits package, including:
Medical, dental, and vision insurance
Paid time off and company holidays
401(k) retirement plan with company match
Annual incentive program
Career advancement opportunities within a growing research organization
Why Join Velocity Clinical Research?
This opportunity allows regulatory professionals to:
Gain hands-on experience in clinical trial regulatory operations
Support accelerated study start-up and compliance initiatives
Work within an integrated clinical research site network
Develop expertise in IRB processes, regulatory audits, and clinical documentation
Advance a long-term career in Regulatory Affairs or Clinical Operations
Keywords for Search Optimization
Regulatory Specialist Jobs, Clinical Research Regulatory Jobs, IRB Submission Jobs, Regulatory Affairs Entry Level, Clinical Trial Regulatory Coordinator, ICH GCP Jobs, FDA Compliance Jobs, Research Site Regulatory Careers, Clinical Study Start Up Jobs
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