Clinical/Translational Research Coordinator

Vanderbilt University Medical Center•Nashville, TN

About The Position

Discover Vanderbilt University Medical Center: Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt’s mission is to advance health and wellness through preeminent programs in patient care, education, and research. Organization: Kidney & Pancreas Transplant Job Summary: The Department of Surgery is seeking an experienced research professional to support solid organ transplant research. Does this sound like you? If so, ideally, you will be someone with previous experience as a clinical research coordinator. You will be coordinating a small pilot clinical trial that will involve reviewing potential candidates in EPIC, contacting them via phone/MyHealth at Vanderbilt and setting up enrollment visits where the research coordinator will then meet the patient and be involved in consent and administering surveys. Other tasks will include using clinical trials related applications for regulatory purposes/data entry and storage (IRB, PEER, RedCap). You also will be responsible for helping patients with downloading an application to their phone and registering for an account within the application. You will be expected to contact patients during the study and set-up follow-up visits. Finally, you will help organize a data safety and monitoring board. Depending on the time requirements for the study, additional tasks will revolve around helping with organizing a research study, doing literature reviews, and gathering/cleaning data. The only strict requirement for this position is a Bachelor's degree (or equivalent experience). However, specific qualities that will lend to success in this role will include the following: • Prior clinical research experience • Strong organizational skills • Self motivation with ability to take initiative • Working independently with minimum supervision • Comfortable interacting with and developing rapport with patients • REDCap experience . DEPARTMENT SUMMARY: The Vanderbilt Division of Kidney and Pancreas Transplantation is one of the oldest and most experienced kidney transplant programs in the United States, having performed over 6,000 transplants since its inception in 1962. We are currently the third largest kidney transplant program in the Southeast. Surgeons perform cadaver and living donor kidney transplants, simultaneous kidney/pancreas transplants, and pancreas transplants alone. The Division was also the first transplant program in Tennessee to introduce the minimally invasive technique of laparoscopic donor nephrectomy for living donor kidney transplants, and now performs the largest number of living donor kidney transplants in the state. For more information, please visit https://www.vumc.org/kidneypancreasetransplantdivision/welcome.

Requirements

Bachelor's degree (or equivalent experience)

Nice To Haves

Prior clinical research experience
Strong organizational skills
Self motivation with ability to take initiative
Working independently with minimum supervision
Comfortable interacting with and developing rapport with patients
REDCap experience

Responsibilities

With assistance, 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
Prepares and maintains documents required to be maintained and available internally and 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
Procures equipment and supplies needed to fulfill project requirements
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
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 assists with study completion, study closeout and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports
With supervision, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance
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 determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. With guidance, 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.
Engages in open and positive communication with study participants and coworkers
With direction, performs or instructs others in performing procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and in a timely manner reports all deviations from the protocol to the Principal Investigator and/or senior personnel who will determine if a protocol amendment or other safety reporting to appropriate funding/regulatory agencies is required
The responsibilities listed are a general overview of the position and additional duties may be assigned.