Specialist II, Regulatory

Role Overview: As a Regulatory Specialist II at Velocity Clinical Research, you will be supporting a team in the preparation and maintenance of complete and accurate regulatory documents essential for clinical research studies. Your role will involve leading a team of regulatory specialists and clinical research coordinators to ensure timely and compliant regulatory submissions, as well as maintaining study binders and coordinating with auditors. Key Responsibilities: - Lead a team of regulatory specialists and/or clinical research coordinators to support Velocity Clinical - Prepare study-specific protocol, informed consent form, HIPAA authorization, and other related documents for IRB review - Ensure timely preparation and submission of initial regulatory documents for IRB and sponsors to expedite study start-up - Submit amendments, annual requests for continuing approval, audits, deviations, adverse event reports, and other required IRB submissions - Assist in completing Financial Disclosure Forms and ensure staff have appropriate training documented - Maintain study binders with all IRB-related documents, track training status, and assist in preparation for monitoring visits and audits - Stay updated on regulatory trends and ensure compliance with changes in regulations - Prepare local IRB and IBC submissions, review informed consent forms for completeness, and ensure availability of study documents in required languages - Collaborate with Velocity IRB for generic site material submissions - Perform other duties as assigned Qualification Required: - Bachelor's degree with 2 years of relevant experience in the life science industry OR - Associate's degree with 4 years of relevant experience OR - High School Graduate with a minimum of 6 years of relevant experience - Proficiency in technology including Microsoft Office, strong organizational and communication skills, ability to work independently and as part of a team, detail-oriented, problem-solving skills - Familiarity with ICH, GCP, and FDA regulatory requirements - Ability to provide on-the-job training and mentor junior staff - Physical abilities to sit or stand for long periods, travel locally and nationally, communicate effectively, and lift up to 30 pounds Company Details: Velocity Clinical Research is a dedicated research site organization focused on delivering innovative medical treatments to patients. As an employee, you will play a crucial role in ensuring the success of clinical trials by generating high-quality data and providing exemplary patient care. Velocity values its employees and offers benefits including medical, dental, and vision insurance, paid time off, retirement plan, and annual incentive program.,