Job Summary: The VCC Manager will provide overall leadership for the local Central Operations (CO) division within the Vanderbilt Coordinating Center (VCC), located within the Vanderbilt Institute for Clinical and Translational Research (VICTR). Working with leadership and CO colleagues, the Manager will develop, implement, and oversee processes, systems, educational programs, standard policies and procedures, and other activities necessary to support, grow, and optimize clinical and translational research studies that are overseen by the VCC at Vanderbilt University Medical Center (VUMC). The CO Manager will provide strategic leadership in this area including planning, goal setting, and monitoring organizational performance to ensure cost effectiveness and high quality programs underneath the direction of the Local Support Services Director.
Education Required: Bachelor's
Education Preferred: Master's
Required time in field previous to employment: 8 Year(s)
LCR Preferred: Registered Nurse (RN); Certified Clinical Research Professional (CCRP); Certified IRB Professional (CIP); Regulatory Affairs Certification (RAC); Project Management Professional (PMP); Master Project Manager (MPM)
1. Develops, evaluates, improves, and supports the ACE (Auditing, Compliance and Education) program within the VCC.
Oversee and define best practices across Local Support Services through internal auditing procedures, risk analysis assessments, and enforcement of internal policies and guidance documents.
Provide oversight during FDA inspections and develop inspection readiness plans; oversight of audits from sponsors and third party vendors (including CROs, pharmacy, technology vendors, and laboratories).
Establish policy working groups, with input and support from leadership, in order to provide content and expertise when developing, updating, and/or confirming processes and regulations outlined within VCC policies. Ensure working groups meet deliverables, members provide content as required, and manage working group timelines.
Develop, implement, and maintain processes within electronic systems, often through the development and updating of REDCap databases, in order to sustain and enhance operational efficiencies.
Oversee the VCC's Clinical Research Educator with the intent to identify gaps in educational knowledge across the VCC. Relay to leadership opportunities and needs for additional education once identified through internal auditing and QA reporting.
Develop tailored educational materials along with creating processes for assessing competencies once new educational materials and/or programs are presented to VCC staff. Oversee educational focused working groups in order to design and ensure the successful implementation of educational materials.
Oversight of initial orientation and ongoing training materials for VCC staff.
Develop and refine local VCC job descriptions in an effort to align them with ongoing assessments of competency and key functions.
Research, analyze, and implement external and internal training programs for local VCC staff.
2. Develops, evaluates, improves, and supports the Clinical Research Navigator program within the VCC.
Provide oversight and direction for the local Clinical Research Navigator team which acts as a central resource for investigators to provide expertise, guidance and education on clinical trials coordination at VUMC.
Develop and refine study startup practices in an effort to improve the quality and timelines associated with new study activation at VUMC.
Maintain a working knowledge of, and when appropriate serve on, clinical research focused institutional committees with the goal of improving clinical research activities across VUMC.
Design, evaluate, and improve data management tools and overall record keeping practices for VCC local studies.
With support from VCC Directors and the VCC Business Manager, develops initial clinical trial budgets for review in order to determine feasibility before clinical trial participation begins. Analyzes and evaluates clinical trial budget variances in order to determine cause.
Advise external and internal study collaborators on institutional practices, policies and workflow.
3. Develop and lead employees within the VCC CO team in an effort to encourage qualified, competent staff that achieve the goals associated with their individual roles.
· Creates an environment that encourages and supports self-development and learning for all staff through regular feedback, by assuring the development of staff through orientation, training programs, work experiences and assessing competencies by meeting the performance expectations stated in his or her job description.
· Models behavior consistent with the mission, vision, and values of the enterprise through leadership, innovation, initiating improvement, and developing new programs.
· Identifies candidates for internal positions, supports candidate recruitment, and utilizes effective interviewing techniques to ensure judicious hiring choices.
· Further develops a comprehensive CO training program, with measures for continued review of relevant content and ongoing competency assessments, and assists in training sessions as needed.
· Defines the qualifications and performance expectations for all staff positions through the Performance Development system, including department specific job descriptions and measurable performance standards.
· Delegates responsibilities to staff within the VCC CO in order to ensure appropriate work assignments and increase work efficiency.
· Supervision includes being responsible for planning, coordinating, and controlling the work and procedures of others and providing advice and consultation for staff as needed.
· Adjusts work schedules or project priorities and milestones in order to meet emergencies or changing conditions.
· Responsible for building and maintaining relationships with VCC staff members in order to foster a sense of ownership and dedication to the goals and mission of the department and institution.
· Creates individual staff development plans to ensure that objectives are being met for various projects and to facilitate continued growth and development of staff.
· Responsible for providing constructive feedback and implementing corrective action for staff members when appropriate.
4. Ensure the most effective operations of the VCC through program development, process improvement and coordination/integration of processes with other departments and collaborating institutions.
Communicates within and across departments and among institutions to maximize effectiveness, efficiency, and information sharing.
Establishes credibility, trust, rapport and a good working relationship with staff, management, and faculty. Promotes a team philosophy and a spirit of open communication and responsiveness.
Establishes and maintains current Standard Operating Procedures and internal guidelines that reflect best practice and increase efficiency and compliance in all areas of VCC CO workflow.
Integrates operational and monitoring controls for new projects throughout proposal development, review, and protocol creation.
Integrates new technology and processes into daily workflow in order to increase efficiency.
Incorporates electronic data capture into daily processes and oversees the creation and maintenance of multiple electronic databases within the VCC that outline current workflow. Serves as an expert for electronic data capture.
Develops reports in order to gain insight into the current financial status, enrollment position, and overall productivity of various projects. Devises corrective action plans and incorporates process improvements when projects are not meeting set objectives.
5. Identify, establish, and evaluate quality assurance standards, programs, and procedures within the VCC in order to maintain compliance with applicable regulations.
Takes a leadership role in ensuring that clinical research programs are of high quality and integrity in compliance with Federal, State, and VUMC guidelines.
Identifies changing areas of clinical research risk and revises policies as needed to address and mitigate those risks; reviews strategies with and establishes working relationships with the larger research, finance and compliance communities.
Serves as in-house expert on compliance matters for clinical research staff and investigators by monitoring regulatory developments in the clinical research arena.
Keeps abreast of new guidelines, national discussions and best practices in the management of conflict of interest and in the protection of human subjects as they relate to the operational aspects of clinical research.
Interface and partner with regulatory bodies who influence policies and regulations that affect research.
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.