Advertisement
Velocity Clinical Research, a leading integrated research site organization, is hiring for the position of Regulatory Specialist I. This role is perfect for life science graduates looking to build a career in clinical research regulatory affairs. Candidates will gain hands-on experience in IRB submissions, regulatory documentation, and GCP compliance, supporting the rapid startup and successful execution of clinical trials.
If you’re detail-oriented and passionate about clinical research, this could be the opportunity you’ve been waiting for.
Key Responsibilities
As a Regulatory Specialist I, you will:
Advertisement
- Prepare study-specific documents including protocols, informed consent forms, and HIPAA authorizations.
- Support initial IRB submissions and ensure regulatory readiness for fast study startup.
- Manage amendments, continuing approvals, deviations, SAE/AE reports, and IRB-required submissions.
- Track staff training compliance and maintain delegation of authority logs.
- Maintain accurate and audit-ready regulatory binders (electronic/paper).
- Support monitoring visits, sponsor audits, and regulatory inspections.
- Assist in study close-out, archival of trial data, and compliance with GCP and FDA regulations.
Qualifications
- Education:
- Bachelor’s degree + 1 year of relevant experience in life sciences, OR
- Associate’s degree + 2 years’ experience, OR
- High School/Technical degree + 3 years’ experience.
- Skills Required:
- Knowledge of ICH, GCP, FDA regulations.
- Strong verbal and written communication.
- Proficiency in Microsoft Office tools.
- Ability to multitask, prioritize, and work independently.
- Detail-oriented with strong organizational skills.
Benefits
Velocity Clinical Research offers:
- Competitive salary (INR 4,00,000 – 6,00,000 annually).
- Medical, dental, and vision insurance.
- Paid time off and company holidays.
- 401(k) retirement plan with company match.
- Annual incentive program.
- Career development opportunities in a global clinical research network.
Application Process
Advertisement
