Vanderbilt University Medical Center Manager, Central Operations in Nashville, Tennessee

VICTR-VCC

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.

Basic Qualifications:

Education

Education Required: Bachelor’s

Education Preferred: Master’s

Experience

Required time in field previous to employment: 8 Year(s)

Licensure, Certification, and/orRegistration (LCR):

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)

Key Functions:

1. Develops,evaluates, improves, and supports the ACE (Auditing, Compliance and Education) programwithin the VCC.

  • Overseeand define best practices across Local Support Services through internalauditing procedures, risk analysis assessments, and enforcement of internalpolicies and guidance documents.

  • Provideoversight during FDA inspections and develop inspection readiness plans;oversight of audits from sponsors and third party vendors (including CROs,pharmacy, technology vendors, and laboratories).

  • Establishpolicy working groups, with input and support from leadership, in order toprovide content and expertise when developing, updating, and/or confirmingprocesses and regulations outlined within VCC policies. Ensure workinggroups meet deliverables, members provide content as required, and manageworking group timelines.

  • Develop,implement, and maintain processes within electronic systems, often throughthe development and updating of REDCap databases, in order to sustain andenhance operational efficiencies.

  • Overseethe VCC’s Clinical Research Educator with the intent to identify gaps ineducational knowledge across the VCC.Relay to leadership opportunities and needs for additionaleducation once identified through internal auditing and QA reporting.

  • Developtailored educational materials along with creating processes for assessingcompetencies once new educational materials and/or programs are presentedto VCC staff.Oversee educationalfocused working groups in order to design and ensure the successfulimplementation of educational materials.

  • Oversightof initial orientation and ongoing training materials for VCC staff.

  • Developand refine local VCC job descriptions in an effort to align them withongoing assessments of competency and key functions.

  • Research,analyze, and implement external and internal training programs for local VCCstaff.

2. Develops,evaluates, improves, and supports the Clinical Research Navigator programwithin the VCC.

  • Provideoversight and direction for the local Clinical Research Navigator teamwhich acts as a central resource for investigators to provide expertise,guidance and education on clinical trials coordination at VUMC.

  • Developand refine study startup practices in an effort to improve the quality andtimelines associated with new study activation at VUMC.

  • Maintaina working knowledge of, and when appropriate serve on, clinical researchfocused institutional committees with the goal of improving clinicalresearch activities across VUMC.

  • Design,evaluate, and improve data management tools and overall record keepingpractices for VCC local studies.

  • With support from VCC Directors and theVCC Business Manager, develops initial clinical trial budgets for reviewin order to determine feasibility before clinical trial participationbegins.Analyzes and evaluates clinicaltrial budget variances in order to determine cause.

  • Adviseexternal and internal study collaborators on institutional practices,policies and workflow.

3. Develop and lead employeeswithin the VCC CO team in an effort to encourage qualified, competent staffthat 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 effectiveoperations of the VCC through program development, process improvement andcoordination/integration of processes with other departments and collaboratinginstitutions.

  • Communicates within and across departments andamong institutions to maximize effectiveness, efficiency, and informationsharing.

  • Establishes credibility, trust, rapport and agood working relationship with staff, management, and faculty. Promotes a team philosophy and a spiritof open communication and responsiveness.

  • Establishes and maintains current StandardOperating Procedures and internal guidelines that reflect best practiceand increase efficiency and compliance in all areas of VCC CO workflow.

  • Integrates operational and monitoring controlsfor new projects throughout proposal development, review, and protocolcreation.

  • Integrates new technology and processes intodaily workflow in order to increase efficiency.

  • Incorporates electronic data capture intodaily processes and oversees the creation and maintenance of multipleelectronic databases within the VCC that outline current workflow. Serves as an expert for electronic datacapture.

  • Develops reports in order to gain insight intothe current financial status, enrollment position, and overallproductivity of various projects.Devises corrective action plans and incorporates processimprovements when projects are not meeting set objectives.

5. Identify, establish, andevaluate quality assurance standards, programs, and procedures within the VCC inorder to maintain compliance with applicable regulations.

  • Takes a leadership role in ensuring thatclinical research programs are of high quality and integrity in compliancewith Federal, State, and VUMC guidelines.

  • Identifies changing areas of clinical researchrisk and revises policies as needed to address and mitigate those risks;reviews strategies with and establishes working relationships with the largerresearch, finance and compliance communities.

  • Serves as in-house expert on compliancematters for clinical research staff and investigators by monitoringregulatory developments in the clinical research arena.

  • Keeps abreast of new guidelines, nationaldiscussions and best practices in the management of conflict of interestand in the protection of human subjects as they relate to the operationalaspects of clinical research.

  • Interfaceand partner with regulatory bodies who influence policies and regulationsthat affect research.

Bachelor's Degree (or equivalent experience) and 5 years experience

Physical Requirements/Strengths needed & Physical Demands:

Movement

  • Occasional: Sitting: Remaining in seated position

  • Occasional: Standing: Remaining on one's feet without moving.

  • Occasional: Walking: Moving about on foot.

  • Occasional: Lifting under 35 lbs: Raising and lowering objects under 35 lbs from one level to another

  • Occasional: Push/Pull: Exerting force to move objects away from or toward.

  • Occasional: Bending/Stooping: Trunk bending downward and forward by bending spine at waist requiring full use of lower extremities and back muscles

  • Occasional: Reaching below shoulders: Extending arms in any direction below shoulders.

  • Occasional: Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands.

Sensory

  • Occasional: Vision: Clarity of near vision at 20 inches or less and far vision at 20 feet or more with depth perception, peripheral vision, color vision.

  • Frequent: Noise: May include exposure to occupational noise levels which equal or exceed an 8-hr time-weighted average of 85 decibels, requiring enrollment in VUMC's Hearing Conservation Program which includes training, use of hearing protection, and periodic audiometry.

  • Continuous: Communication: Expressing or exchanging written/verbal/electronic information.

Job Research

Organization: VICTR Vanderbilt Coord Center 104241

Title: Manager, Central Operations

Location: TN-Nashville-Village at Vanderbilt

Requisition ID: 1805598