Regulatory Specialist at Velocity Clinical Research
Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data, and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high-quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step
As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.
Position Type: Regular Full-Time
Telecommute: No
Overview:
Become a part of Velocity Clinical Research as a Regulatory Specialist I, where you will play a crucial role in preparing and maintaining complete and accurate regulatory documents in support of clinical research studies.
Summary:
The Regulatory Specialist I prepares and maintains complete and accurate regulatory documents in support of clinical research studies
.Responsibilities:
- Prepare each study-specific protocol, informed consent form, HIPAA authorization, and other related documents for review by the IRB.
- Support initial regulatory submission documents for IRB and sponsors to ensure site compliance with regulatory readiness metrics.
- Ensure timely regulatory submissions to avoid study start-up delays.
- Prepare and submit amendments, requests for continuing approval, audits, deviations, adverse event reports, and other IRB-required submissions.
- Work on completing Financial Disclosure Forms for each study.
- Assist in tracking training status for staff and ensuring appropriate documentation is on file.
- Maintain study binder with all IRB-related documents for audit readiness.
- Assist in preparation for monitoring visits, sponsor audits, and regulatory audits.
- Support maintenance of logs and any required submissions as necessary.
- Submit or support SAE and AE submissions to the IRB as needed.
- Provide documentation to sponsors, as required.
- Adhere to safety and compliance regulations.
- Perform other duties as assigned.
Qualifications:
Education/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 and/or technical degree with a minimum of 3 years relevant experience in the life science industry
Required Skills:
- Demonstrated knowledge of medical terminology.
- Proficiency in using computers, Microsoft Office software, fax, copier, and multi-line telephone.
- Strong verbal, written, and organizational skills.
- Ability to work as a team player and independently with guidance.
- Detail-oriented and flexible.
- Understanding of ICH, GCP, and FDA regulatory requirements.
Required Physical Abilities:
- Ability to sit or stand for long periods of time.
- Travel locally and nationally as needed.
- Effective communication abilities.
- Limited walking and lifting up to 30 pounds.
Keywords: Velocity Clinical Research, Specialist I, Regulatory, Regulatory Specialist, Clinical Research, Life Science, Regulatory Documents
