Job Description – Regulatory Specialist I
Company: Velocity Clinical Research
Location: [Not specified]
Department: Clinical Research / Regulatory Affairs
Job Type: Full-time
About Velocity Clinical Research
Velocity Clinical Research is an integrated research site organization delivering excellence in patient care, high-quality data, and fully integrated research operations. We are committed to making clinical trials succeed by generating data quickly and effectively, while ensuring exemplary patient care.
As an employee, you play a critical role in our mission. Velocity supports career advancement, rewards high performance, and welcomes both newcomers and industry veterans to apply.
Benefits include:
Medical, dental, and vision insurance
Paid time off & company holidays
401(k) retirement plan with company match
Annual incentive program
Role Summary
The Regulatory Specialist I prepares and maintains accurate regulatory documentation to support clinical research studies, ensuring compliance and audit readiness.
Key Responsibilities
Regulatory Submissions & Documentation
Prepare study-specific protocols, informed consent forms, HIPAA authorizations, and other regulatory documents for IRB review.
Support initial submissions to IRB and sponsors to meet regulatory readiness metrics.
Submit amendments, continuing approvals, deviations, adverse event reports, and other required IRB submissions in a timely manner.
Maintain regulatory binders (paper/electronic) with IRB documents and correspondence for each study.
Assist with the preparation and submission of study closeout documents and archival of trial data.
Training & Compliance
Track and assist staff in completing required research documentation and trainings.
Monitor training status and update as needed for existing staff.
Ensure all individuals on delegation of authority (DOA) logs have appropriate training records.
Notify staff and managers of upcoming training expirations.
Audit & Inspection Readiness
Conduct quality checks of regulatory binders to ensure audit readiness.
Support preparation for monitoring visits, sponsor audits, and regulatory inspections.
Provide IRB documents to sponsors as required.
Safety & Reporting
Support timely SAE and AE submissions to the IRB.
Ensure compliance with ICH, GCP, FDA regulatory requirements, and company SOPs.
Adhere to all safety and compliance regulations.
Other Duties
Assist site leadership, coordinators, and new hires as needed.
Maintain logs (e.g., DOA, other required logs).
Perform additional duties as assigned.
Qualifications
Education & Experience
Bachelor’s degree + minimum 1 year relevant life sciences experience OR
Associate’s degree + minimum 2 years relevant experience OR
High school diploma/technical degree + minimum 3 years relevant experience
Skills & Competencies
Knowledge of medical terminology
Strong verbal, written, organizational, and interpersonal skills
Proficient in Microsoft Office, computers, and basic office equipment
Ability to multi-task, prioritize, and work independently or in a team
Detail-oriented, flexible, and adaptable to clinic needs
Professionalism and accountability
Understanding of ICH, GCP, FDA regulations
Ability to communicate effectively in English
Physical Requirements
Sit/stand for long periods
Limited walking and lifting (up to 30 lbs)
Local and national travel as needed
Communicate in person and via phone
Note
This job description outlines the general role expectations and may change as company needs evolve. All employees are expected to perform duties within their abilities as directed by management.
✨ Join Velocity Clinical Research – where your regulatory expertise drives clinical trial success.
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