Clinical/Translational Research Coord II- Hybrid

Vanderbilt University Medical Center•Nashville, TN

2d•Hybrid

About The Position

The Clinical/Translational Research Coordinator II supports newly funded research in Vanderbilt Health’s Department of Anesthesiology. The coordinator recruits and consents study participants, performs study procedures, records research data, and conducts participant assessments in their homes. The position is hybrid: in-person work is required when needed for participant activities, while work that does not require face-to-face contact with participants or colleagues may be completed from home. Reliable transportation is required for local travel, and mileage is reimbursed. The coordinator prepares and maintains regulatory and study documentation, supports participant screening and enrollment, records and manages study data, and helps ensure studies follow institutional policies, federal regulations, sponsor requirements, and good clinical practice. The role also involves specimen handling and shipping, support for study budgets and billing compliance, communication with study stakeholders, and protection of human research participants. The position is primarily Monday through Friday during traditional daytime business hours, but study needs may require early, late, or weekend hours; flexibility is crucial.

Requirements

Bachelor’s degree or equivalent experience.
At least 1 year of relevant experience.
Proficiency with Microsoft 365.
Reliable transportation for required local travel.

Nice To Haves

Experience with Epic.
Experience with REDCap.

Responsibilities

Prepare and process new IRB research proposals, amendments, continuing review applications, and adverse event reports in accordance with institutional and departmental policies, procedures, and federal regulations.
Prepare and maintain study documents required for internal records and review by 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 study procedures.
Identify and procure equipment and supplies needed for project requirements, locally and across multiple sites when required.
Help determine participant eligibility and verify that participants meet study requirements.
Use screening and recruitment strategies and complete documentation to support timely study completion.
Assess potential participants’ medical and historical information to determine suitability for enrollment and continued participation.
Record data from source documents or participant interactions on paper or electronic case report forms accurately, completely, and on time; resolve queries promptly.
Collect and store research information in compliance with applicable regulations, policies, and good clinical practice.
Package and ship study specimens, such as blood or urine, in accordance with sponsor, laboratory, shipping, and regulatory requirements, 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 by maintaining communication with investigators, research staff, sponsors, participants, participant advocates, professional organizations, and the public, and by monitoring trial processes and participant protections.
Participate in the informed consent process and help ensure participants, families, and health care providers understand what is expected during trial participation.
Participate in research-related programs, including the Clinical/Translational Research Staff Council, and share information with research personnel.
Recruit and consent participants, perform study procedures, record study data, and conduct participant assessments in their homes.
Support research operations through project coordination, documentation, tracking, and related administrative and logistical activities.