Clinical Trials Navigator

Clinical Trials Navigator / Regulatory Project Manager Location: Remote Contract: 12 months (with potential to extend) Overview: Seeking an experienced Clinical Trials Navigator / Regulatory Project Manager to support multi-center clinical research projects. This position will play a key role in managing regulatory startup activities, facilitating IRB submissions, and supporting the coordination of new clinical trial sites.Responsibilities:Manage and coordinate regulatory startup activities for multi-site clinical trials.Lead efforts related to central and single IRB submissions, including document preparation, tracking, and communication with participating sites.Utilize IREX to organize and monitor startup activities, ensuring timely progress through all stages.Support site activation, initial visits, and documentation review to ensure compliance with institutional and federal requirements.Draft and manage sponsor and regulatory documents such as consent instructions, IRB forms, and ClinicalTrials.gov submissions.Collaborate with cross-functional teams across Vanderbilt, industry partners, and other academic centers to support project timelines.Engage with the IND/FDA process as needed to support ongoing studies.Perform quality control reviews to maintain data integrity and ensure all submissions meet regulatory and institutional standards.Work closely with project managers and investigators to develop, track, and maintain regulatory timelines.Qualifications:5+ years of experience in clinical research, ideally within an academic medical center environment.Hands-on experience with single IRB and central IRB processes.Knowledge of multi-center trial coordination and site startup workflows.Experience with ClinicalTrials.gov submissions, IND documentation, and FDA correspondence preferred.Familiarity with REDCap, IREX, and Veeva Vault systems.Strong attention to detail and ability to manage complex regulatory processes across multiple sites.Excellent communication and organization skills with the ability to work cross-functionally.Background as a Clinical Research Coordinator, Data Manager, or Regulatory Specialist strongly preferred.