Bodien - ON SITE

Vanderbilt University Medical Center•Nashville, TN

3d•Onsite

About The Position

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. 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.

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.
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

Nice To Haves

Clinical Research (Novice): Can research problems that span several areas of the department. Develops and writes basic trial protocols. Knows what information is available in the company. Designs data collection forms. Has developed networking skills which assist in researching issues.
Study Design & Conduct (Novice): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.
Project Coordination (Novice): Reviews specific project related documents for completeness and accuracy and ensures project status reports are received, when due, from project managers for all approved projects. Provides administrative and logistics support for various project meetings, training, workshops and facilitated sessions. Coordinates and tracks all work requests to ensure on time project delivery. Keeps project plans updated and ensures key milestones and dependencies are understood. Responsible for record keeping for project meetings such as issues logs, gap analysis sheets, meeting minutes, making copies, team event planning and execution, team travel, on-boarding activities for contractors or consultants, set up and maintenance of project repositories.
Communication (Novice): Clearly, effectively and respectfully communicates to employees or customers.

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.