Life Sciences Job at Velocity Clinical Research | Regulatory Specialist
Velocity Clinical Research, an owned and integrated research site organization committed to accelerating innovative medical treatments, is seeking a Specialist I, Regulatory. This dedicated life sciences job focuses on preparing and maintaining complete and accurate regulatory documents essential for clinical research studies. If an applicant has a Bachelor’s degree and at least 1 year of relevant experience, along with a firm understanding of ICH, GCP, and FDA regulations, they should apply now to drive regulatory compliance for this leading site organization.
- Designation: Specialist I, Regulatory
- Category: Regulatory
- Position Type: Regular Full-Time
- Telecommute: No
About The Company
Velocity Clinical Research is focused on making clinical trials succeed by generating high-quality data from as many patients as possible, as quickly as possible, while providing exemplary patient care. Velocity is committed to career advancement and rewarding high performance.
Key Responsibilities
The Regulatory Specialist I plays a critical role in ensuring all regulatory documentation is accurate, current, and ready for audit or inspection.
- IRB & Initial Submissions: Prepare study-specific protocol, ICF (Informed Consent Form), HIPAA authorization, and other related documents for IRB review. Supports initial regulatory submission documents for IRB and sponsors to ensure expedited study start-up.
- Maintenance & Lifecycle: Prepare and submit amendments, yearly requests for continuing approval, audits, deviations, adverse event reports, and any other IRB-required submissions. Assist with preparing and submitting closeout documents to sponsors and IRBs.
- Documentation & Audit Readiness: Maintain the study binder (paper or electronic) with all IRB-related documents and correspondence to ensure audit readiness at all times. Assist site leadership in the preparation for monitoring visits, sponsor audits, and regulatory audits by conducting quality checks of the regulatory binder.
- Staff Training Support: Assist new hires and existing staff in completing and submitting all required research documentation and training, including tracking status and notifying staff of upcoming expirations.
Qualifications and Experience
Regulatory compliance jobs requires foundational experience in clinical research operations:
Education & Experience (Meet one criterion)
- 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 a minimum of 3 years relevant experience in the life science industry.
Required Skills
- Regulatory Knowledge: Demonstrated understanding of ICH, GCP, and FDA regulatory requirements.
- Technical Skills: Proficient use of Microsoft Office software and general office technology.
- Core Abilities: Must be detail-oriented; demonstrated ability to multitask, work independently, plan, and prioritize.
- Domain: Demonstrated knowledge of medical terminology.
If an applicant is a detail-oriented professional with essential experience in the life sciences job sector and a firm understanding of ICH/GCP, this regulatory compliance jobs role is an excellent entry point into specialized regulatory operations. They should apply now to join Velocity Clinical Research and contribute to the successful execution of clinical trials.
