Clinical/Translational Research Coordinator II

Vanderbilt University Medical Center•Nashville, TN

About The Position

The Clinical/Translational Research Coordinator II coordinates the approval processes and conduct of clinical and translational research protocols, maintaining research integrity and quality and ensuring work complies with applicable policies. The position performs this work under occasional guidance and supports studies throughout their life cycle, including regulatory preparation, participant screening and enrollment, data collection, specimen handling, documentation, and billing compliance. The coordinator supports human-subject protections by maintaining communication with investigators, research staff, sponsors, participants, and other stakeholders, and by participating in the informed consent process. The role also provides project coordination and administrative support, including tracking project work and maintaining records. Additional duties may be assigned.

Requirements

Bachelor's degree.
At least 1 year of relevant work experience.
Ability to communicate clearly, effectively, and respectfully with employees or customers.

Responsibilities

Assist with preparing new IRB research proposals, amendments, continuing review applications, and adverse event reports in accordance with institutional and departmental policies and procedures and federal regulations.
Prepare and maintain accurate, compliant study documents for internal use and review by regulatory authorities or sponsors before, during, and after clinical or translational trials.
Participate in site visits from sponsors, regulatory authorities, and others to review research, source documentation, critical documents, and research procedures.
Identify and procure equipment and supplies needed for projects, including across multiple sites when required.
Help determine participant eligibility and ensure participants meet study requirements.
Support timely study completion by implementing screening and recruitment strategies and completing required documentation.
Assess potential participants' relevant medical and historical information to ensure appropriate enrollment and continued eligibility.
Record source and participant-interaction data on paper or electronic case report forms accurately, completely, and promptly, and resolve queries in a timely manner.
Ensure research information is collected and stored in compliance with regulations, policies, and good clinical practice.
Package and ship study specimens to sponsors or laboratories in accordance with sponsor instructions and shipping regulations, maintaining appropriate documentation.
Manage study invoicing under direction and take appropriate action to maintain clinical trial billing compliance; provide 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 and help ensure participants, families, and healthcare providers understand expectations for trial participation.
Develop and write basic trial protocols and design data collection forms.
Review project documents for completeness and accuracy, track work requests, update project plans, and monitor milestones and dependencies.
Provide administrative and logistical support for project meetings, training, workshops, and facilitated sessions.
Maintain project records such as issue logs, gap analysis sheets, and meeting minutes; support team event planning, travel, contractor or consultant onboarding, and project repository maintenance.