Are you passionate about clinical research and regulatory compliance? Velocity Clinical Research is hiring a Specialist I, Regulatory to join our dynamic team. This full-time role is perfect for individuals with a background in life sciences and a strong understanding of regulatory requirements in clinical trials. If you’re detail-oriented, organized, and thrive in a fast-paced environment, this could be the perfect opportunity for you.
Velocity Clinical Research is a leading integrated research site organization dedicated to bringing innovative medical treatments to patients. We pride ourselves on delivering high-quality data, exemplary patient care, and efficient study execution. Our mission is to make clinical trials succeed by ensuring compliance, accuracy, and patient safety at every step.
As a Specialist I, Regulatory, you’ll play a critical role in maintaining the integrity of our clinical trials by ensuring all regulatory documents are accurate, complete, and audit-ready.
Key Responsibilities of the Regulatory Specialist I
As a Regulatory Specialist I, you will:
- Prepare and submit study-specific protocols, informed consent forms, and HIPAA authorizations for IRB review.
- Ensure timely regulatory submissions to meet study start-up timelines.
- Maintain regulatory binders (paper or electronic) to ensure audit readiness.
- Submit amendments, continuing approval requests, and adverse event reports to the IRB.
- Assist in tracking and updating staff training and delegation of authority logs.
- Support the preparation for monitoring visits, sponsor audits, and regulatory inspections.
- Submit SAE (Serious Adverse Event) and AE (Adverse Event) reports to the IRB as required.
- Ensure compliance with ICH, GCP, and FDA regulatory requirements.
- Collaborate with site leadership and coordinators to maintain regulatory readiness.
Qualifications for the Regulatory Specialist I Role
Education and 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 or technical degree with a minimum of 3 years of relevant experience in the life science industry.
Required Skills:
- Strong knowledge of medical terminology and regulatory requirements.
- Proficiency in using Microsoft Office, fax machines, copiers, and multi-line telephones.
- Excellent verbal, written, and organizational skills.
- Ability to work independently and as part of a team.
- Detail-oriented with strong multi-tasking abilities.
- Understanding of ICH, GCP, and FDA guidelines.
Physical Abilities:
- Ability to sit or stand for long periods.
- Limited lifting (up to 30 pounds).
- Local and national travel may be required.
Why Join Velocity Clinical Research?
At Velocity, we value our employees and invest in their growth. Here’s what we offer:
- Comprehensive Benefits: Medical, dental, and vision insurance.
- Paid Time Off: Generous PTO and company holidays.
- Retirement Plan: 401(k) with company match.
- Career Advancement: Opportunities for growth and development.
- Annual Incentive Program: Rewards for high performance.
