Velocity Clinical Research is a leading integrated research site organization dedicated to delivering excellence in patient care, high-quality data, and fully integrated research sites. Our mission is to bring innovative medical treatments to patients by ensuring clinical trials succeed through efficient processes, exemplary patient care, and robust data generation. At Velocity, we value our employees as the cornerstone of our success and invest in their growth, offering opportunities for career advancement and performance-based rewards.
Why Join Velocity?
- Competitive benefits including medical, dental, and vision insurance.
- Paid time off and company holidays.
- 401(k) retirement plan with company match.
- Annual incentive program.
- A supportive and collaborative work environment focused on professional development.
Job Description:
Velocity Clinical Research is seeking a Regulatory Specialist I to join our dynamic team. In this role, you will play a critical part in ensuring the accuracy and completeness of regulatory documents, supporting the successful execution of clinical research studies.
Key Responsibilities:
- Prepare and submit study-specific protocols, informed consent forms, HIPAA authorizations, and other regulatory documents for IRB review.
- Support initial regulatory submissions to IRBs and sponsors to meet regulatory readiness metrics and expedite study start-up.
- Ensure timely submissions of amendments, continuing approvals, audits, deviations, and adverse event reports.
- Maintain accurate and audit-ready regulatory binders (paper or electronic) for all studies.
- Assist in the preparation and submission of closeout documents to sponsors and IRBs.
- Track and manage staff training status, ensuring compliance with study requirements.
- Support the maintenance of Delegation of Authority (DOA) logs and other essential study logs.
- Assist in preparing for monitoring visits, sponsor audits, and regulatory inspections.
- Submit SAEs and AEs to IRBs in a timely manner.
- Adhere to safety, compliance, and regulatory guidelines (ICH, GCP, FDA).
Qualifications:
- Education:
- Bachelor’s degree with 1 year of relevant experience in the life science industry, OR
- Associate’s degree with 2 years of relevant experience, OR
- High School Graduate/technical degree with 3+ years of relevant experience.
- Required Skills:
- Proficiency in medical terminology and regulatory requirements (ICH, GCP, FDA).
- Strong organizational, verbal, and written communication skills.
- Ability to multi-task, work independently, and prioritize effectively.
- Detail-oriented with a focus on accuracy and compliance.
- Proficient in Microsoft Office and other relevant technology.
- Physical Abilities:
- Ability to sit or stand for long periods.
- Limited lifting (up to 30 pounds) and walking required.
