With guidance and training, is responsible for coordinating the approval processes and conduct of research protocols, such that the integrity and quality of the clinical/translational research is maintained and the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research protocols. This position manages clinical trial enrollment from planning through study closeout.
Vanderbilt University Medical Center's Department of Emergency Medicine is a national leader in emergency care research. Led by 8 core faculty and an extensive research infrastructure, we are top leaders in designing innovative ED-based research and are top enrollers in both industry and federally funded studies. Our research staff actively screens patients over 100 hours each week in the emergency departments at VUMC and the Tennessee Valley Hospital. Combined, these Eds see over 100,000 patients each year. To ensure timely enrollment in therapeutic studies, the research faculty are immediately available to assist the student team on a daily basis. For more information, please visit https://vanderbiltem.com/em-research.
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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 Adult Hospital in Tennessee and metropolitan Nashville, named to the Best Hospitals Honor Roll of the top 20 adult hospitals, 10 nationally ranked adult specialty programs, with 3 specialties rated in the top 10 nationally, Monroe Carell Jr. Children's Hospital at Vanderbilt named as one of the Best Children's Hospital in the nation, with 10 out of 10 pediatric specialties nationally ranked.
* Healthcare's Most Wired: Among the nation's 100 "most-wired" hospitals and health systems for its efforts in innovative medical technology.
* Becker's Hospital Review: named as one of the "100 Great Hospitals in America", in the roster of 100 Hospitals and Health Systems with Great Oncology Programs and to its list of the 100 Hospitals with Great Heart Programs.
* The Leapfrog Group: One of only 10 children's hospitals in the to be named at Leapfrog Top Hospital.
* American Association for the Advancement of Science: The School of Medicine has 112 elected fellows
* Magnet Recognition Program: Received our third consecutive Magnet designations.
* National Academy of Medicine: 22 members, elected by their peers in recognition of outstanding achievement
* Human Rights Campaign Healthcare Equality Index: 6 th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.
Key Functions and Expected Performances
Conveys a basic knowledge and understanding of policies, procedures, and regulations governing human subject's 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, reviews new IRB research proposals, amendments, continuing review applications and reports adverse event reports according to institutional and departmental policies and procedures and federal regulations and provides feedback for study execution.
Attends designated site initiation visits, monitor and study specific conference calls.
With guidance, coordinates and manages daily enrollment and follow up activities to capture protocol compliant data points within designated timeframes.
Exhibits the capability to understand and follow a clinical/translational study protocol, obtaining training and seeking assistance when needed, to safely and accurately perform or assess required protocol procedures.
Coordinates optimal schedule coverage to capture enrollment activities according to individual study requirements.
Collaboratively coordinates study participants, other staff and departments to complete research protocols, including performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, completing required participant registration in electronic medical record, conducting interviews and laboratory and diagnostic studies, tracking medication usage and other protocol specific investigational 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) with awareness and attention to the requirements for accuracy, completeness and timeliness.
Attends to query resolution per protocol when necessary.
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 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 .
Serves as lead Coordinator for observational device and biomarker trials conducted by Emergency Medicine Research from start up to completion of the study.
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
Collaborates with team members to determine necessary safety reporting requirements of the study protocol, IRB, FDA and other regulatory bodies.
Able to detect and report adverse events to investigators and team leaders.
With guidance, sets up clinical trials and studies for study execution in the healthcare environment from start up through completion.
Coordinates activities and gathers information from a variety of sources to achieve stated outcomes
Performs processing, 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
Coordinates subject compensation, enrollment log activities to capture study budget requirements accurately, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing information to investigators, department administration and funding agencies.
Collaboratively participates and/ or leads in study team meetings. Maintains open and positive communications with investigators, participants, co-workers, other departments and sponsors.
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.
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.
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.
Encourages open communication with participants by providing them with contact information and being available to answer, address or refer their calls.
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 require
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 preparation of manuscripts for publication.
Participates in and maintains certifications, licensure and credentialing as required by Vanderbilt, the department and Sponsor.
With assistance, develops and achieves personal and professional goals.
This is a non-exempt position; M-F with weekend and holiday coverage possible.
Salary is dependent upon education and experience.
Background screens will be performed, and education will be verified prior to employment. Please be prepared to provide required information and/or documentation.
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 t...he 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.