Regulatory Affairs Jobs at Velocity Clinical Research | Life Sciences | Apply Now
Velocity Clinical Research is an owned and integrated research site organization dedicated to providing excellence in patient care and generating high-quality data. This Regulatory Affairs Job (ID 2026-3385) is a Regular Full-Time position designed for professionals who want to lead the charge in bringing innovative medical treatments to patients. As a Specialist II, you serve as the most integral part of the mission, ensuring that clinical trials succeed through meticulous documentation and expedited start-up processes. Whether you are an industry veteran or a rising star, a Velocity Career offers a structured environment where high performance is recognized and rewarded with an annual incentive program.
- Job Position: Specialist II, Regulatory
- Category: Regulatory
- Job ID: 2026-3385
About the Company
Velocity Clinical Research provides fully integrated research sites focused on making clinical trials succeed by generating data from as many patients as possible. The core objective is to bring innovative treatments to patients quickly while maintaining exemplary care at every step. Velocity invests in career advancement for talented candidates who perform at a high level. Employees receive medical, dental, and vision insurance, a 401(k) with company match, and paid time off.
Key Responsibilities: Regulatory Affairs Jobs
In this Regulatory Affairs Job, you will lead a team to ensure regulatory readiness and audit compliance across one or more Velocity sites.
- Team Leadership: Leads multiple regulatory specialists and clinical research coordinators to support site-specific operations.
- Submission Preparation: Prepares protocols, Informed Consent Forms (ICFs), HIPAA authorizations, and related documents for IRB review.
- Expedited Start-Up: Focuses on meeting regulatory readiness metrics to ensure study start-ups are not delayed.
- Binder Maintenance: Maintains paper or electronic study binders with all IRB correspondence to ensure constant audit readiness.
- Quality Oversight: Conducts quality checks of regulatory binders for monitoring visits, sponsor audits, and regulatory audits.
- Specialized Review: Reviews ICFs to ensure the California Bill of Rights is included as applicable and that subject stipends are accurately captured.
- Training & Compliance: Tracks training status for staff and notifies site leadership of upcoming expiration dates to maintain delegation of authority logs.
- Study Close-Out: Ensures all close-out documents are complete, audit-ready, and properly archived at the conclusion of a study.
Qualification and Experience: Life Sciences Jobs
To qualify for these Life Sciences Jobs, candidates must meet a tiered set of education and industry experience requirements.
- Educational Tiers:
- Bachelor’s degree with 2 years of relevant life science industry experience.
- Associate’s degree with 4 years of relevant experience.
- Preferred Certification: Being a Certified Clinical Research Professional (CCRP) is considered a plus for this role.
- Technical Proficiency: Proficient in Microsoft Office and clinical trial management technology.
- Regulatory Literacy: Must have a proficient understanding of ICH, GCP, and FDA regulatory requirements.
- Leadership & Soft Skills: Demonstrated leadership ability with strong problem-solving and organizational skills to prioritize tasks with minimal guidance.
- Communication: Excellent verbal and written communication skills in English are required.
In summary, the Specialist II, Regulatory position at Velocity Clinical Research is a definitive Life Sciences Job for those who thrive in fast-paced, high-accountability environments. A Velocity Career provides the unique opportunity to lead teams and manage the entire regulatory lifecycle—from initial IRB submission to final archiving. Your attention to detail in tracking staff training and ensuring ICF completeness directly impacts the safety and success of the trials. If you are a team player ready to mentor junior staff and uphold the highest standards of ICH-GCP, Velocity is the place to advance your career.
