With guidance and training, this position is primarily responsible for overseeing the development of the VUMC Heart Valve Registry, in accordance with Good Clinical Practice Guidelines and Vanderbilt Policy and Procedures. Essential tasks for this role will include regular 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. A secondary responsibility will involve assisting with the enrollment and study visits for patients included in industry-supported device trials or other related trials. Overall, the role will involve interacting in a rapidly evolving research and 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. This may include data entry, checking/running queries for completeness/accuracy as well as ensuring Federal and VUMC policies are being followed
Exhibits good time management and flexibility in collecting participant measurements surrounding a clinical procedure (may need to be available early in the morning or in the evening)
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; encourages open communication with participants by providing them with contact information and being available to answer, address or refer their questions.
Conveys a basic knowledge and understanding of policies, procedures, and regulations governing human subjects research and incorporates them in the conduct of research:
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), before engaging in human subjects research
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
Communicates a basic knowledge and understanding of the management and implementation of clinical/translational research operations
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 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
Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements
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. Coordinates activities and gathers information from a variety of sources to achieve stated outcomes
With supervision, develops and manages study budgets, 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
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
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 who will determine if a protocol amendment or other safety reporting to appropriate funding/regulatory agencies is required
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
Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Pursues avenues to continue education (i.e., in-services, seminars, etc.)
Demonstrates initiative for continuous learning, both self-directed and as evidenced by attendance of educational and professional development opportunities. Actively seeks new learning opportunities, seeing learning as part of work
Engages in a minimum of 5 hours of continuous, job-related educational activities annually or pursuing an advanced career-related academic education or certification
Participates in and maintains certifications, licensure and credentialing as required by Vanderbilt, the department and Sponsor
Furthers knowledge base by attending a Basic Research 101 within first three months of employment date
Bachelor's Degree (or equivalent experience) and < 1 year(s) experience
Prior to advancing to a Clinical/Translational Research Coord II, must complete a Research 101 course such as RSS Boot camp
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. It is a place where your diversity -- of culture, thinking, learning and leading -- 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.
VUMC Recent Accomplishments
Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments:
US News & World Report: #1 Hospital in Tennessee, #1 Health Care Provider in Nashville, #1 Audiology ( Bill Wilkerson Center ), 9 adult and 9 pediatric clinical specialties ranked among the nation's best, #15 Education and Training
Truven Health Analytics: among the top 100 hospitals in the US
Becker's Hospital Review: one of the "100 Greatest Hospitals in America"
The Leapfrog Group: grade "A" in Hospital Safety Score
National Institutes of Health: among the top 10 grant awardees for medical research in the US
American Association for the Advancement of Science: 12 faculty members elected fellows in 2014
Magnet Recognition Program: Vanderbilt nurses are the only group honored in Middle Tennessee
Nashville Business Journal: Middle Tennessee's healthiest employer
American Hospital Association: among the 100 "Most Wired" medical systems in the US
Vanderbilt University Medical Center is home to Vanderbilt University Hospital, The Monroe Carell Jr. Children’s Hospital at Vanderbilt, the Vanderbilt Psychiatric Hospital and the Vanderbilt Stallworth Rehabilitation Hospital. These hospitals experienced more than 61,000 inpatient admissions during fiscal year 2015. Vanderbilt’s adult and pediatric clinics treated nearly 2 million patients during this same period.Vanderbilt University Hospital and the Monroe Carell Jr. Children’s Hospital at Vanderbilt are recognized again this year by U.S. News & World Report’s Best Hospitals as among the nation’s best with 18 nationally ranked specialties. Vanderbilt University Medical Center is world renowned because of the innovation, work ethic and collegiality of its employees. From our health care advances to our compassionate care, Vanderbilt owes its accomplishments and reputation to staff and faculty who bring skill and drive and innovation to the medical center day after day. World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.As th...e largest employer in middle Tennessee, we welcome those who are interested in ongoing development in a caring, culturally sensitive and professional atmosphere. Most of us spend so much of our lives at work, we want to be part of maintaining a workplace in which people support one another and encourage reaching for excellence. Many high-achieving employees stay at Vanderbilt because of the professional growth they experience and because of their appreciation of Vanderbilt’s benefits, public events and discussions, athletic opportunities, beautiful setting and, above all, sense of community and purpose.Vanderbilt and its employees share a set of mutual expectations that have been created with productivity, legality, fairness and safety always in mind. We believe that our investment in training and compensating employees multiplies in value when we enable individuals to deliver their best performance for the benefit of us all.