Clinical/Translational Research Coordinator II

Vanderbilt University Medical Center•Nashville, TN

About The Position

The Clinical/Translational Research Coordinator II coordinates research approval processes and the conduct of clinical and translational research protocols, maintaining research integrity and quality and ensuring compliance with applicable policies. The role works under occasional guidance and may receive additional duties. The coordinator prepares and processes IRB submissions and maintains regulatory and study documentation; supports sponsor and regulatory site visits; procures study equipment and supplies; helps identify, screen, recruit, and enroll eligible participants; collects and manages study data; resolves data queries; and packages and ships specimens according to sponsor and regulatory requirements. With direction, the coordinator also develops and manages study budgets and monitors invoicing and billing compliance. The role advocates for human research participants, supports the informed consent process, and communicates with investigators, research staff, sponsors, participants, and other relevant stakeholders. It also participates in research-related programs and staff council activities. The position is part of Vanderbilt Health’s Infectious Disease Research organization and supports its academic research mission.

Requirements

At least 1 year of relevant work experience.
Bachelor’s degree.
Ability to prepare and process IRB submissions and maintain research and regulatory documentation in accordance with applicable policies and regulations.
Ability to support participant eligibility assessment, screening, recruitment, informed consent, and ongoing trial participation.
Ability to collect and manage clinical research data accurately and resolve queries in a timely manner.
Ability to follow sponsor and regulatory requirements for specimen packaging and shipping.
Communication skills to interact clearly, effectively, and respectfully with colleagues, customers, and research stakeholders.
Knowledge or capability in clinical research, study design and conduct, project coordination, and communication at the novice level.

Responsibilities

Prepare and process new IRB research proposals, amendments, continuing review applications, and adverse event reports in accordance with institutional, departmental, and federal requirements.
Prepare and maintain study documents required for internal records and review by sponsors or regulatory authorities before, during, and after clinical or 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 projects, including across multiple sites when required.
Help determine candidate eligibility, implement screening and recruitment strategies, complete required documentation, and assess participants’ medical and historical information for enrollment and continued eligibility.
Record data from source documentation or participant interactions on paper or electronic case report forms, ensure accuracy, completeness, and timeliness, and 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, support clinical trial billing compliance, and provide reports to investigators, department administration, and funding agencies.
Advocate for human research participants 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 informed consent process and help ensure participants, families, and other health care providers understand what participation in a trial entails.
Participate in research-related programs and Clinical/Translational Research Staff Council activities, including submitting issues or solutions, reviewing council information, attending meetings, and sharing information with research personnel.