LINK TO APPLY: https://vanderbilt.taleo.net/careersection/.vu_cs/jobdetail.ftl?job=2009362
With guidance and training, this position is responsible for overseeing the development and maintenance of the VUMC Heart Valve Registry as well as Industry Sponsored Heart Valve Clinical Trials (Edwards Lifesciences, Boston Scientific, Medtronic, etc.). Essential tasks for this role will include regular database entry and oversight, participant interaction, consenting, survey administration, specimen collection, large/complex database management, data entry surrounding participant procedures, accurate and timely documentation, regulatory maintenance, tracking follow-up appointments, etc. The candidate should be proficient in data management and interact in a rapidly evolving clinical setting, in collaboration with the heart valve team, to ensure study- related procedures are performed as required and timelines are met.
-Ability to oversee large and consistently evolving databases. May include data entry, checking/running queries for completeness/accuracy, etc.
-Exhibits good time management and flexibility in collecting participant measurements surrounding a clinical procedure (may need to be available early in the mornings or late in the evenings some days)
-Communicates with the heart valve team/other coordinators to quickly see referred inpatients or last-minute add-ons and collect all protocol related documents/measures with awareness and attention to the requirements for accuracy, completeness and timeliness
-Monitors/manages timely data collection for patients and tracking updates/clinic visits in EPIC.
-Meticulous and detail oriented with the ability to organize/file documents consistently and in a way that colleagues/study teams can identify. This includes maintaining original source documentation, utilizing systematic processes, and timely filing/data entry with awareness of good documentation practices.
-Interacts with patients in a friendly manner that represents VUMC well
-Possesses a basic awareness of the Federal regulations and guidelines governing the protection of human subjects (e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations)
-Understands and complies with protocol procedures/VUMC policies/OSHA precautions on handling biospecimens; including collection, processing, storage, dissemination, and shipping.
-Exhibits the capability to understand and follow a study protocol, obtain training and seek assistance when needed, to safely and accurately perform or assess required protocol procedures. -Prepares and maintains documents required to be maintained and available internally and for regulatory authorities and/or the Sponsor (i.e. Edwards, Boston Scientific, Medtronic, etc.) as well as for periodic site visits.
-Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. This may include interpreting (w/ guidance from Valve Team Physicians) Echocardiograms, EKGs, CTs, Medication History, Past Medical History, etc.
-Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic). Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice
-Familiar with the safety reporting requirements of the study protocol, FDA and other regulatory bodies. In a timely fashion, monitors, detects and reports adverse events meeting requirements of regulatory bodies.
-Assists in monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance
-Collaboratively participates in study team meetings. Maintains open and positive communications with investigators, participants, co-workers, other departments and sponsors
-Engages in open and positive communication with study participants and coworkers -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
-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.
-Utilizes or obtains knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to the principal investigator and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations.
-Participates in and maintains certifications, licensure and credentialing as required by Vanderbilt, the department and Sponsor
-Bachelor's Degree in field of Science (Required); Master's Degree in relevant field desired
-Minimum of 2 years of relevant experience in some previous research environment (Required); preferably patient interaction
Additional Salary Information: PTO, health insurance, 401k, and varies health/career benefits.
Internal Number: 2009362
About Vanderbilt University Medical Center
The Vanderbilt University Medical Center (VUMC) Heart Valve Program is a leader in treating heart valve disease with the newest transcatheter techniques and helping develop the next big innovations in the field. Established in 2017, the heart valve research team is a collaborative research group led by Dr. Brian Lindman committed to investigating transcatheter and adjunctive therapies for patients with valvular heart disease through translational and clinical research. Our multidisciplinary team includes cardiologists, interventional cardiologists, cardiac surgeons, echocardiologists, radiologists, biostatisticians, research analysts, research coordinators, and administrative staff.