Clinical/Translational Research Coordinator II

Vanderbilt University Medical Center•Nashville, TN

About The Position

The Clinical/Translational Research Coordinator II coordinates research protocol approval processes and study conduct to maintain the integrity and quality of clinical/translational research and ensure compliance with applicable policies. The role performs these responsibilities under occasional guidance and supports studies throughout their lifecycle, including regulatory submissions, participant recruitment and monitoring, data collection, specimen handling, and budget administration. The coordinator also supports human-subject protections, maintains communication among investigators, research staff, sponsors, participants, and other stakeholders, and participates in research-related programs and staff council activities. The role may receive additional duties as assigned.

Requirements

Bachelor’s degree.
At least 1 year of relevant work experience.
Ability to prepare and process research regulatory submissions and maintain clinical/translational trial documentation.
Ability to support participant eligibility screening, recruitment, informed consent, and ongoing study participation.
Ability to collect and record study data accurately and resolve data queries in a timely manner.
Knowledge of applicable research regulations, policies, and good clinical practice.
Ability to communicate clearly, effectively, and respectfully with employees and customers.

Responsibilities

Prepare and process new IRB research proposals, amendments, continuing review applications, and adverse event reports in accordance with institutional and departmental policies and federal regulations.
Prepare and maintain required study documents for internal use and availability to regulatory authorities or sponsors 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 study requirements, locally and across multiple sites when necessary.
Participate in determining candidate eligibility and ensure participants meet study requirements.
Support timely study completion by implementing screening and recruitment strategies and completing required documentation.
Assess potential participants’ medical and historical information to ensure appropriate enrollment and continued eligibility.
Record data from source documents or participant interactions on paper or electronic case report forms accurately, completely, and on time; resolve queries promptly.
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 according to sponsor instructions and shipping regulations, maintaining appropriate documentation.
With direction, develop and manage study budgets, monitor invoicing, maintain clinical trial billing compliance, and provide reports to investigators, department administration, and funding agencies.
Advocate for human subjects by maintaining communication with investigators, research staff, sponsors, participants, professional organizations, participant advocates, and the public, and by monitoring trial processes and participants.
Participate in the informed consent process and help ensure participants, families, and health care providers understand expectations for trial participation.
Participate in research-related programs, including the Clinical/Translational Research Staff Council and its activities, and share information with research personnel.
Provide project coordination and administrative support, including document review, status tracking, meeting and training logistics, project records, and milestone tracking.