Specialist II, Regulatory | Clinical Research | Velocity Clinical Research
Company: Velocity Clinical Research
Job ID: 2026-3385
Job Type: Full-Time (Permanent)
Work Mode: On-site (No Telecommute)
Experience: 2–6+ Years (depending on qualification)
Location: Not explicitly specified (Multi-site / Clinical Research Locations)
Job Overview
Velocity Clinical Research is seeking a Specialist II, Regulatory to support clinical trials by managing regulatory documentation, IRB submissions, and compliance processes. This role is critical in ensuring that clinical studies meet ICH-GCP, FDA, and regulatory standards, while enabling fast and efficient study start-up.
If you're aiming to build expertise in clinical research operations, regulatory affairs, and trial compliance, this role provides hands-on exposure to IRB processes, audits, and global regulatory frameworks.
Key Responsibilities
Regulatory Submissions & Compliance
Prepare and submit regulatory documents to Institutional Review Boards (IRB) and sponsors
Manage protocols, informed consent forms (ICFs), HIPAA authorizations, and amendments
Ensure timely submissions to avoid delays in clinical trial start-up
Clinical Trial Documentation
Maintain regulatory binders (paper/electronic) ensuring audit readiness
Handle continuing review submissions, deviations, adverse event reports
Ensure proper documentation for study close-out and archiving
Audit & Inspection Readiness
Support monitoring visits, sponsor audits, and regulatory inspections
Conduct quality checks and ensure compliance with SOPs
Coordinate meetings with auditors and manage document reviews
Team Leadership & Coordination
Lead and guide regulatory specialists and clinical research coordinators
Assist in onboarding and training of new staff
Track training compliance and maintain staff documentation
Stakeholder Collaboration
Work with site leadership, sponsors, and IRB teams
Provide regulatory documentation support to sponsors
Ensure consistency of regulatory processes across sites
Regulatory Intelligence & Process Improvement
Stay updated on evolving FDA, ICH-GCP, and regulatory guidelines
Improve regulatory workflows and documentation standards
Support local IRB and IBC submissions
Required Skills & Qualifications
Education & Experience
Bachelor’s degree + 2 years clinical research experience
OR
Associate’s degree + 4 years experience
OR
High School/Technical degree + 6 years experience
Certifications (Preferred)
Certified Clinical Research Professional (CCRP) – a plus
Technical Skills
Strong understanding of ICH-GCP, FDA regulations, and clinical trial compliance
Experience with IRB submissions, regulatory documentation, and audit processes
Knowledge of clinical trial documentation (ICF, protocol, regulatory binders)
Familiarity with clinical research systems and Microsoft Office tools
Core Competencies
Excellent organizational and documentation skills
Strong communication and stakeholder management
Ability to multitask in a fast-paced clinical environment
Leadership and mentoring capability
High attention to detail and problem-solving mindset
Perks & Benefits
Comprehensive medical, dental, and vision insurance
Paid time off and company holidays
401(k) retirement plan with company match
Annual performance-based incentive program
Career advancement opportunities in clinical research and regulatory affairs
Work in a patient-centric, innovation-driven clinical environment
Compensation
Salary Range: Not disclosed (competitive based on experience and industry standards)
About the Company
Velocity Clinical Research is a leading integrated clinical research site organization focused on high-quality data generation, patient care, and accelerated clinical trials. With a strong emphasis on innovation and compliance, Velocity supports the development of new medical treatments and therapies globally.
Why This Role is High-Value
This role is ideal for professionals looking to grow in:
Clinical Research & Trial Operations
Regulatory Affairs & Compliance
Pharmacovigilance & Drug Safety Support
Clinical Documentation & Audit Readiness
Global Clinical Trials & FDA Regulations
Application Process
Apply directly through the company’s official careers page.
Call to Action
If you want to become a core player in clinical trials and regulatory compliance, this role puts you right at the center of drug development.
Step into high-impact clinical research, regulatory excellence, and global trial execution.
Apply now and accelerate your career in pharma and clinical research. 🚀
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