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

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 biologi

Requirements

• Bachelor's degree (or equivalent experience)
• 1 year of relevant experience
• Prior to advancing to a Clinical/Translational Research Coordinator II, must have completed a Research 101 course such as RSS Boot camp; applicant/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, daytime business hours
• Flexibility is essential, with occasional weekend work as needed
• .
• DEPARTMENT SUMMARY :
• KEY COMPETENCIES
• Knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in securing approval for and the conduct of research
• Knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations
• Knowledge and understanding of the implementation, coordination, management and reporting of clinical/translational research operations

Benefits

Additional Information

Discover Vanderbilt University Medical Center : Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt's mission is to advance health and wellness through preeminent programs in patient care, education, and research. Organization: Section Surgical Research Job Summary: In your pivotal role as a Clinical/Translational Research Coordinator II (CTRC II), you will join the Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center's Traumatic Brain Injury (TBI) Hub-a collaborative program managing multiple federally funded, local, and multi-center interventional and observational studies. Our mission is to improve clinical care and long-term outcomes for patients with acute brain injury, including individuals with disorders of consciousness. To advance this mission, our team identifies, screens, enrolls, and follows patients from the acute hospital setting through long-term recovery. As a CTRC II, you will partner with local and national Principal Investigators (PIs) and multidisciplinary clinical teams to support the development, implementation, and day-to-day execution of research protocols and standard operating procedures (SOPs). You'll play a key role in ensuring studies are conducted with accuracy, consistency, and a strong commitment to participant-centered research. What success looks like in this role: Our environment is dynamic, fast-paced, and mission-driven. The strongest candidates bring: 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

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