Clinical/Translational Research Coord II- Hybrid

Vanderbilt University Medical Center•Nashville, TN

15h•Hybrid

About The Position

In your pivotal role as Clinical/Translational Research Coordinator II, you will support newly funded research. You will recruit and consent participants for participation in studies, perform study procedures and record study data. Your duties will include performing assessments in participants’ homes. This position is hybrid. You must be available in person when necessary for participant activities and may work from home for activities that do not require face-to-face contact with participants or colleagues. While your hours will be primarily Monday-Friday, traditional daytime business hours, your schedule may vary based on study specific needs, which may include early, late and weekend hours. Flexibility is crucial in this role.

Requirements

Bachelor's Degree (or equivalent experience)
At least 1 year of relevant experience
Proficiency with Microsoft 365
Reliable transportation, as local travel will be required; mileage will be reimbursed

Nice To Haves

Experience with Epic & REDCap is helpful

Responsibilities

Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations
Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures
Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)
Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation. Assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation
Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness. Attends to query resolution in a timely manner. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Participates in site visits from sponsor, regulatory authorities and others to review research, source documentation, critical documents and research procedures
Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation
With direction, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports investigators, department administration and funding agencies
Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants
Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them in the course of participating in a clinical/translational trial
Participates in research related programs, such as the Clinical/translational Research Staff Council and its activities by submitting issues or suggesting solutions, and reviewing Council information, by attending meetings open to research staff and by sharing information with other research personnel