Clin/Tran Research Coord II - Maiga/Bodien - ON SITE

Job Summary In your pivotal role as a Clinical/Translational Research Coordinator II (CTRC II) you will work with the Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center’s Traumatic Brain Injury (TBI) Hub. You will partner with local and national Principal Investigators and multidisciplinary clinical teams to support the development, implementation, and day‑to‑day execution of research protocols and standard operating procedures (SOPs). Your work will ensure studies are conducted with accuracy, consistency, and a strong commitment to participant‑centered research. Key Success Qualities Excellent written and verbal communication skills. Strong attention to detail and organizational skills. Initiative and sound judgment in a clinical research setting. Adaptability and comfort managing competing priorities. A mindset of continuous improvement and process optimization. Key Responsibilities Prepare, submit, and manage IRB applications (new studies, amendments, continuing reviews, and adverse event reports) in compliance with institutional policies and federal regulations. Conduct and support study procedures, including participant screening, recruitment, scheduling, informed consent, interviews, assessments, specimen collection, and assisting with EEG/MRI and other protocol‑required activities. Accurately collect, document, and enter study data from source documents into paper or electronic case report forms, ensuring completeness, accuracy, and timeliness. Prepare, maintain, and organize regulatory and essential study documents to ensure ongoing compliance with Good Clinical Practice (GCP). Monitor participant safety by identifying, documenting, and reporting adverse events in accordance with protocol, IRB, FDA, sponsor, and institutional requirements. Coordinate packaging and shipment of biological specimens in compliance with sponsor, laboratory, and shipping regulations, maintaining required documentation. Participate in site visits, audits, and monitoring activities by sponsors and regulatory authorities, addressing queries and resolving findings in a timely manner. Collaborate professionally with investigators, participants, sponsors, and multidisciplinary teams, serving as an advocate for human subject protections. Assist with study operations, including equipment and supply procurement, budget development and tracking, invoicing, and ensuring clinical trial billing compliance. Engage in ongoing professional development through required training, certifications, research councils, and continuous education to maintain and advance clinical research expertise. Qualifications Bachelor’s degree (or equivalent experience). 1 year of relevant experience in clinical or translational research. Completion of a Research 101 course such as the RSS Boot Camp before advancing to the CTRC II role; a new hire must complete a Research 101 course within six (6) months of hire. Work Location and Schedule On‑site at Vanderbilt Medical Center North (21st Ave., Nashville, TN). Schedule is primarily Monday‑Friday during daytime business hours. Flexibility is essential, with occasional weekend work as needed. Vanderbilt Health is committed to fostering an environment where everyone has the chance to thrive and is committed to the principles of equal opportunity. EOE/Vets/Disabled. #J-18808-Ljbffr Direct Jobs