Clin/Tran Research Coord II

Vanderbilt University Medical Center•Nashville, TN

1d•Onsite

About The Position

The Clinical/Translational Research Coordinator II (CTRC II) joins the Critical Illness, Brain Dysfunction, and Survivorship Center’s Traumatic Brain Injury Hub, a collaborative program managing federally funded, local, and multi-center interventional and observational studies. The team works to improve clinical care and long-term outcomes for patients with acute brain injury, including people with disorders of consciousness, by identifying, screening, enrolling, and following patients from acute hospitalization through long-term recovery. The CTRC II partners 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. The role helps ensure studies are conducted accurately and consistently, with a commitment to participant-centered research and human-subject protections. The position is on-site at Vanderbilt Medical Center North in Nashville, Tennessee. The schedule is primarily Monday through Friday during daytime business hours, with occasional weekend work as needed. Vanderbilt Health offers a comprehensive benefits package that may include health, disability, retirement, and wellness offerings.

Requirements

Bachelor’s degree or equivalent experience.
One year of relevant experience.
Must have completed a Research 101 course, such as RSS Boot Camp, before advancing to Clinical/Translational Research Coordinator II; applicants or new hires must complete a Research 101 course within six months of hire.
Knowledge and understanding of policies, procedures, and regulations governing human-subject research, and ability to apply them when securing approval and conducting research.
Knowledge and understanding of federal regulations and guidelines for human-subject protections, including FDA, OHRP, GCP/ICH, and HIPAA regulations.
Knowledge and understanding of clinical/translational research operations, including implementation, coordination, management, and reporting.
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.
Commitment to continuous improvement and process optimization.

Responsibilities

Prepare, submit, and manage IRB applications, including 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 assistance with EEG, MRI, and other protocol-required activities.
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 support ongoing Good Clinical Practice compliance.
Monitor participant safety by identifying, documenting, and reporting adverse events according to protocol, IRB, FDA, sponsor, and institutional requirements.
Coordinate the packaging and shipment of biological specimens in accordance with sponsor, laboratory, and shipping regulations, maintaining required documentation.
Participate in sponsor and regulatory authority site visits, audits, and monitoring activities; address queries and resolve 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 clinical trial billing compliance.
Participate in required training, certifications, research councils, and continuing education to maintain and advance clinical research expertise.