Velocity Clinical Research is a leading research site organization dedicated to advancing medical treatments through clinical trials. With a strong focus on patient care and high-quality data collection, Velocity strives to deliver exceptional outcomes. As part of this organization, employees are integral to its mission of providing innovative medical solutions to patients. Velocity offers a collaborative environment, where career growth and employee satisfaction are a top priority. Their benefits package includes medical, dental, and vision insurance, paid time off, company holidays, a 401(k) retirement plan, and annual incentives.
Responsibilities in the Job
As a Specialist I, Regulatory, you will play a key role in supporting clinical research by ensuring that regulatory documents are accurate and complete. Key responsibilities include:
- Preparing and maintaining study protocols, informed consent forms, and other related documents.
- Supporting initial regulatory submissions to meet study readiness metrics.
- Ensuring timely submission of regulatory documents to avoid delays in study startup.
- Preparing and submitting amendments, audit reports, and other IRB-required documents.
- Assisting with Financial Disclosure Forms and tracking staff training documentation.
- Maintaining study binders and assisting in audit readiness.
- Supporting site leadership during sponsor and regulatory audits.
Qualifications
To qualify for this position, applicants must meet the following criteria:
- Bachelor’s degree with 1 year of relevant experience in the life sciences industry, OR
- Associate’s degree with 2 years of relevant experience, OR
- High School Graduate or technical degree with 3 years of relevant experience.
Required Skills
- Strong knowledge of medical terminology and FDA regulatory requirements.
- Proficiency with Microsoft Office, computers, and multi-line phones.
- Excellent verbal, written, and organizational skills.
- Ability to work independently, prioritize tasks, and adapt to clinic needs.
- Detail-oriented, professional, and a strong team player.
