Regulatory Specialist I Role – at Velocity Clinical Research, Apply Now!
Do you have a passion for clinical research and ensuring compliance with FDA, ICH, and GCP regulatory standards? Velocity Clinical Research, Inc., a leading clinical trials site management organization, is seeking a Regulatory Specialist I to support the preparation and maintenance of regulatory documents for clinical studies. In this role, you’ll contribute to regulatory submission processes, ensure audit readiness, and support compliance documentation—making a real impact in advancing clinical research. If you’re detail-oriented, thrive in a collaborative environment, and are ready to grow your career in life sciences, apply today!
Position: Specialist I, Regulatory
Responsibilities for Regulatory Specialist I Role:
- Prepare study-specific protocol, informed consent form, HIPAA authorization, and other related documents for review by the IRB
- Support initial regulatory submission documents to ensure expedited study start-up
- Submit amendments, annual requests, audits, adverse event reports, and other required documents to the IRB
- Assist in tracking training status for staff and maintaining study binders
- Support monitoring visits, sponsor audits, and regulatory audits
- Provide copies of IRB documents to sponsors
- Adhere to safety and compliance regulations
- Other duties as assigned
Qualifications Education/Experience:
- Bachelor’s degree with 1 year of relevant experience in the life science industry OR
- Associate’s degree with 2 years of relevant experience in the life science industry OR
- High School Graduate and/or technical degree with minimum of 3 years relevant experience in the life science industry
Required Skills:
- Demonstrated knowledge of medical terminology
- Proficiency in Microsoft Office software and other technology
- Excellent verbal, written, and organizational skills
- Ability to work independently and as part of a team
- Detail-oriented with ability to prioritize tasks
- Understanding of ICH, GCP, and FDA regulatory requirements
Required Physical Abilities:
- Sit or stand for long periods of time
- Local and national travel
- Communicate effectively in person and by phone
- Ability to lift up to 30 pounds
Keywords: Regulatory Specialist, Clinical Research, Life Science Industry, Regulatory Documents, IRB, Compliance
