Job Title: Regulatory Specialist I

Company: Velocity Clinical Research

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About Us:
Velocity Clinical Research is an integrated research site organization dedicated to providing excellence in patient care, high-quality data, and innovative medical treatments. Our mission is to ensure the success of clinical trials by generating high-quality data quickly while maintaining exemplary patient care. We invest in our employees’ career advancement and reward high performance. Join us, whether you’re new to clinical research or an industry veteran.

Benefits:

• Medical, dental, and vision insurance
• Paid time off and company holidays
• 401(k) retirement plan with company match
• Annual incentive program

Job Summary:
The Regulatory Specialist I is responsible for preparing and maintaining complete and accurate regulatory documents in support of clinical research studies.

Key Responsibilities:

• Prepare study-specific protocols, informed consent forms, HIPAA authorizations, and other related documents for IRB review.
• Support initial regulatory submission documents for IRB and sponsors, focusing on expedited study start-up.
• Ensure timely regulatory submissions to avoid study start-up delays.
• Prepare and submit amendments, yearly requests for continuing approval, audits, deviations, adverse event reports, and other IRB-required submissions.
• Assist staff in completing Financial Disclosure Forms for each study.
• Support new hires in completing and submitting required research documentation and training.
• Track training status for existing staff, assisting with updates as needed.
• Ensure all staff on delegation of authority logs have appropriate training on file.
• Maintain study binders with all IRB-related documents and correspondence for audit readiness.
• Notify staff and Site Manager/Director of upcoming training expiration dates.
• Assist in preparing for monitoring visits, sponsor audits, and regulatory audits by conducting quality checks of the regulatory binder.
• Support the preparation and submission of closeout documents to sponsors and IRBs, ensuring completeness and audit-readiness.
• Maintain DOA logs and other required logs as needed.
• Submit or support SAE and AE submissions to the IRB in a timely manner.
• Ensure accurate and timely file completion to support audit and inspection readiness.
• Provide copies of IRB documents to sponsors as needed.
• Adhere to safety and compliance regulations.
• Perform other duties as assigned.

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:

• Knowledge of medical terminology.
• Proficiency with computers, Microsoft Office, fax, copier, and multi-line telephone.
• Strong verbal, written, and organizational skills.
• Excellent interpersonal and communication skills.
• Ability to work as a team player.
• Proficiency in reading, writing, and speaking English.
• Ability to multitask and follow written guidelines.
• Ability to work independently, plan, and prioritize with some guidance.
• Flexibility and adaptability according to clinic prioritization needs.
• Detail-oriented and responsible for individual actions.
• Professionalism under judgment, critique, and praise.
• Understanding of ICH, GCP, and FDA regulatory requirements.

Physical Abilities:

• Ability to sit or stand for long periods.
• Ability to travel locally and nationally.
• Effective communication in person and by telephone.
• Limited walking and lifting up to 30 pounds.

Note: This job description is intended to outline the general functions of the position and may change as the company, department, and circumstances evolve. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.

Apply now to join our mission in bringing innovative medical treatments to patients through successful clinical trials!

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