Clinical Research Regulatory Coordinator
The Lowcountry Center for Veterans Research (LCVR) is a forward-thinking non-profit organization dedicated to improving the overall health and well-being of veterans through discovery and innovation of ground-breaking medical treatments and procedures.
The Regulatory Coordinator will manage all regulatory aspects of study start-up, protocol amendments, annual reporting, and study close-out as they relate submission to Institutional Review Board (IRB) and any relevant regulatory agencies including, Subcommittee on Research Safety (SRS), VA Research & Development Committee (R&DC), and the clinical trial sponsor. The Regulatory Coordinator is responsible for ensuring all required documentation is initiated and maintained completely, accurately, and timely.
Duties & Responsibilities:
• Initiate and maintain accurate and comprehensive regulatory documentation as required by the sponsor in accordance with Good Clinical Practice (GCP), VA R&D, and FDA guidelines.
• Facilitate the timely preparation, review, and submission of all required documents to the appropriate IRB, VA R&DC, FDA, and sponsors
• Prepare and submit amendments, yearly requests for continuing approval of open protocols, audits, and any other IRB or R&D required submissions
• Work closely with clinical research coordinators and investigators prior to submission of study specific documents
• Work with staff members to complete conflict of interest paperwork for each study
• Work with group members to complete required research training and paperwork
• Track training status of existing study staff, assisting with updates as needed
• Acts as an agent of the investigators and research team on matters related to regulatory start-up, regulatory close-out, and other general regulatory documentation
• Maintain excellent and efficient working relationships with sponsors, CROs, and VA R&D staff to ensure their needs are met in a timely and efficient manner.
• Assist with sponsor and internal monitoring visits and reviews and provide regulatory support to effectively meet the needs of monitors and auditors during site visits
• Provide copies of IRB and contractual documents to collaborators, as needed
• Work effectively and cooperatively with others in achieving organizational goals; maintain harmonious working relationships with fellow employees
• Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Qualifications and Hiring Criteria:
• Authorization to work in the US to apply for this job and are subject to a background/suitability investigation
• Education: Requires an associate's degree with 3+ years of relevant experience or a bachelor's degree
• Applicant must have the ability to work proactively and independently in a fast-paced environment and to prioritize and manage the workflow of multiple projects
• Demonstrated attention to detail, ability to meet tight deadlines, professional initiative, teamwork, and reliability is expected
• Must be able to work diplomatically and professionally with administration, faculty, and clinical personnel.
• Ability to simplify and distill complex concepts into clear and concise language
• Strong problem-solving capabilities
Using the position title as the subject, email a completed application and resume to:
Lowcountry Center for Veterans Research
Attn: Brittany Baber