JOB SUMMARY: Responsible for management and evaluation of research programs, assuring objectives are met and integrity and quality of the research is maintained. Assures research is conducted in accordance with Good Clinical Practice Guidelines, federal/sponsor regulations and guidelines, Vanderbilt Policy and Procedure, research protocols and sponsor requirements. Plans, implements and manages or provides oversight of the research from planning to completion, analysis and reporting. Responsible for or provides oversight for communication with the sponsor, IRB, DSMB, regulatory agencies and other research related entities. Functions as a departmental resource for research operations, a leader and role model, supervisor, consultant and educator. Ensures the most effective operation through program development, performance monitoring, process improvement and coordination of processes across functions.
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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.
Advanced knowledge and understanding of policies, procedures, and regulations governing human subject's research and stipulations of sponsor contracts or requirements and incorporates them in the conduct of research. Compliantly, accurately and proficiently prepares, processes, and manages new research proposals, amendments, continuing review applications, adverse event reporting, budgets, and D&H accounts.
Functions as a departmental resource, consultant and educator for the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations
Functions as a departmental resource regarding the policies and procedures and requirements of Vanderbilt departments involved in the approval and proficient and compliant conduct of research (IRB, grants, contracts, finance, etc.)
Expert knowledge and understanding of the management and implementation of clinical/translational research operations
Understands, implements, and follows a clinical/translational study protocol and is able to conduct multiple studies independently. (Able to identify when training is needed to safely and accurately perform or assess required procedures. Prepares, provides and/or participates in needed training). Problem solves when needed
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 or provides oversight of periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures. Prepares reports and statistical analyses and participates in data quality assurance reviews
Identifies and procures equipment and supplies needed to fulfill project requirements. During protocol development, determines equipment and supply needs across the project, assures adequate budget and identifies suppliers
Assists in identifying eligibility criteria for a protocol and assessing feasibility of recruiting and enrolling adequate populations locally and at participating sites. Monitors recruitment across projects, implementing process improvement to assure projects are completed in a timely manner
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. Assists in determining data variables, in designing data dictionaries, and in developing data collection tools and databases and quality assurance processes.
Knowledgeable of 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. Assures programs are compliant with reporting requirements. Identifies the need for and provides oversight, education and training when appropriate
Oversees the management of research samples. Receives and tracks receipt and status of study specimens from multiple sites. 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. Develops study specific standard operating procedures and tracking tools for specimen processing and handling. Develops systems and procedures for the processing and management of research samples. Ensures that all program staff have completed appropriate training as required
Digests complex clinical/translational information to determine if documentation is accurate and, complete. Understands standard of care versus research and its application in billing compliance. Participates in budget and contract negotiation and facilitates interactions between sponsors and institutional departments.
Responsible for project completion processes including timely study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data, performing periodic quality checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports and assuring archival of appropriate/required documentation. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice
Independently manages operational issues for large single and multi-center clinical/translational trials, including interacting with participating sites in the management of coordinating center activities, training, budget and invoicing, reporting to investigators, department administration and funding agencies
Facilitates study and project related team meetings. Maintains open and positive communications with investigators, participants, co-workers, other departments and sponsors
Utilizes coordination skills to complete all research protocols, including patient recruitment, screening, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication tracking and other protocol specific investigational procedures. Facilitates protocol, case report form and research tool/template development and analysis and reporting processes. Assists with the preparation of IND/IDE and regulatory related correspondence
Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, representatives of professional organizations, participant advocates, and members of 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
Performs procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and reporting as required by policy, regulations or protocol, to the sponsor and regulatory agencies
Utilizes or acquires knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to the principal investigator, DSMB and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations
Actively identifies the need for and participates in training, education, and development activities to improve own knowledge and that of the research department and to learn about and improve research related processes (i.e., research, literature searches, research seminars, in-services, 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 15 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
Seeks to participate in research related programs, such as the Clinical/translational Research Staff Council and its activities by serving as a department representative, submitting issues or suggesting solutions, and reviewing Council meeting information, attending meetings open to research staff and by sharing information with other research personnel in the department
Participates and presents in local, national and international conferences. Actively participates in publishing opportunities. Develops and achieves personal and professional goals
Assesses for and implements process improvement initiatives within a clinical/translational trial and across a research department, to assure research quality and expedient completion of recruitment, timely receipt of research related payments and cost savings and expedient study reporting
Facilitates process improvement in clinical research management to speed up study activation, implementation, conduct, close out and reporting
Defines and uses metrics to drive performance improvement. Shares metrics with investigators and superiors to demonstrate areas in need of improvement and track metrics to demonstrate effectiveness of improved processes
Networks with other research departments and colleagues to share best practices
Develops recruitment and retention strategies to improve study performance
Continually revises operating procedures to assure quality and human subjects' protection
Facilitates the education of departmental research staff regarding the importance of contributing to metrics, process improvement and responsible conduct of research
Serves as a role model, mentor, supervisor and consultant across teams and departments to provide expertise and share knowledge
Assists with orientation of new research staff by serving as an available resource, presenting at educational sessions, guiding new staff to attend useful educational sessions, e.g., IRB updates
Develops tools to assist new and junior staff and keeps information current according to changing research requirements
Creates an environment that encourages and supports self-development and learning through regular, immediate feedback
Assures the development of staff members through orientation, training programs and work experience. Strives to develop individualized professional development plan to guide staff to success, focusing on areas needing growth
Exhibits strong leadership skills. Applies key concepts of facilitative leadership
Assigns and reviews work; effectively prioritizes tasks and work assignments. Delegates tasks as appropriate and follows up to assure completion. Plans, organizes, and completes projects in an efficient manner
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.