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Velocity Clinical Research, a leading integrated clinical research site network, is hiring a Regulatory Specialist I to support regulatory documentation, IRB submissions, and study start-up activities. This is an excellent opportunity for candidates seeking growth in clinical research regulatory affairs, IRB documentation, and GCP-compliant trial operations.
This role is ideal for candidates who are detail-oriented, quality-focused, and passionate about advancing clinical trials through robust regulatory oversight.
Key Responsibilities
As a Regulatory Specialist I, you will be responsible for:
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- Preparing study-specific protocols, informed consent forms, HIPAA authorization, and IRB documents.
- Supporting initial regulatory submissions to IRB and sponsors, ensuring regulatory readiness and expedited study start-up.
- Ensuring timely submission of amendments, continuing review applications, deviations, adverse event reports, and audit-related documentation.
- Managing Financial Disclosure Forms for each study.
- Supporting onboarding and training compliance for new hires.
- Tracking staff training records and maintaining delegation of authority logs.
- Maintaining electronic/paper regulatory binders for audit readiness.
- Assisting in monitoring visits, sponsor audits, regulatory inspections, and quality checks.
- Supporting SAE/AE submissions to the IRB with accuracy and timeliness.
- Preparing closeout documents for sponsors and IRBs.
- Ensuring adherence to ICH-GCP, FDA guidelines, and site SOPs.
Required Qualifications
Education
Candidates may qualify through any of the following:
- Bachelor’s degree + 1 year of relevant life science experience
- Associate’s degree + 2 years of relevant experience
- High School or Technical degree + 3 years of relevant experience
Skills & Competencies
- Strong knowledge of medical terminology, ICH-GCP, FDA regulations
- Proficiency with Microsoft Office, computers, scanners, multi-line phone systems
- Excellent written and verbal communication skills
- Strong organizational and multi-tasking abilities
- Ability to work independently and as part of a team
- Detail-oriented, professional, and quality-driven
- Ability to manage priority shifts according to clinic needs
Physical Requirements
- Ability to sit/stand for long periods
- Limited walking and lifting (up to 30 lbs)
- Local and national travel when required
Benefits
Velocity Clinical Research offers:
- Medical, dental, vision insurance
- Paid time off and company holidays
- 401(k) with employer match
- Annual incentive program
- Career advancement in regulatory affairs and clinical operations
How to Apply
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