Clinical/Translational Research Coordinator II

Vanderbilt University Medical Center•Nashville, TN

17h

About The Position

The Clinical/Translational Research Coordinator II coordinates the approval processes and conduct of research protocols, maintaining the integrity and quality of clinical/translational research and ensuring it is conducted in accordance with applicable policies. The role works under occasional guidance within Vanderbilt Health’s Allergy, Pulmonary and Critical Care Medicine organization. The coordinator supports protocol submissions and regulatory documentation; assists with participant screening, recruitment, eligibility, informed consent, and ongoing study participation; records and manages study data; coordinates specimen packaging and shipment; and supports trial billing and invoicing. The role also helps ensure research information, procedures, and records comply with institutional policies, regulations, sponsor requirements, and good clinical practice. The position involves communication with investigators, research staff, sponsors, participants, and other stakeholders, and may include additional duties as assigned.

Requirements

Bachelor’s degree.
One year of relevant work experience.

Responsibilities

Assist with preparing new IRB research proposals, amendments, continuing review applications, and adverse event reports in accordance with institutional and departmental procedures and federal regulations.
Prepare and maintain required study documents accurately and compliantly before, during, and after clinical/translational trials.
Participate in site visits by sponsors, regulatory authorities, and others to review research, source documentation, critical documents, and research procedures.
Identify and procure equipment and supplies needed for project requirements, locally and across multiple sites when required.
Help determine candidate eligibility, implement screening and recruitment strategies, complete required documentation, and assess relevant medical and historical information to support appropriate enrollment and continued participation.
Record data from source documents and participant interactions on paper or electronic case report forms, address queries promptly, and ensure research information is collected and stored in compliance with regulations, policies, and good clinical practice.
Package and ship study specimens, such as blood and urine, in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation.
With direction, manage study invoicing and take appropriate action to maintain clinical trial billing compliance, providing reports to investigators, department administration, and funding agencies.
Advocate for human subjects through communication with investigators, research staff, sponsors, participants, professional organizations, participant advocates, and the public, and through ongoing monitoring of trial processes and participants.
Participate in the ongoing informed consent process, ensuring participants, their families, and other health care providers understand expectations for trial participation.
Support project coordination, including document review, status reporting, meeting and training logistics, work-request tracking, project-plan updates, milestone tracking, record keeping, and maintenance of project repositories.