Clinical Trials Manager

Job Summary:

Independently direct and manage research activities for the departments research initiatives. Manage and coordinate research studies and personnel; educate staff on project research protocols; act as central resource person. Coordinate the completion of research proposals/protocols under which human subjects may be involved; compile protocol information and ensure compliance with federal regulations; support the activities of Principle Investigators in accordance with federal, state, local, institutional, and any other appropriate guidelines, policies, and procedures. Maintain HIPAA compliance knowledge and adhere to all HIPAA regulations as prescribed by Vanderbilt University Medical Center. Maintain knowledge of and comply with all pertinent Vanderbilt University Medical Center policies.

Department/Unit Summary:

Vanderbilt-Ingram Cancer Center (VICC) is a leader in the prevention, diagnosis and treatment of cancer. The centers world-renowned team of experts provides a integrated, personalized and patient-centered approach to cancer care, including treatment, research, support, education and outreach. From a wide variety of wellness programs to a leading REACH for Survivorship Clinic, patients find support from diagnosis through survivorship. VICC is a National Cancer Institute-designated Comprehensive Cancer Center, one of just two centers in Tennessee and 51 in the country to earn this highest distinction, and ranks in the top 10 nationwide for cancer research grant support. Here is a link to our website - http://www.vicc.org/

Position Shift:

• First Shift

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Discover Vanderbilt University Medical Center:

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.

Additional Key Elements/ Responsibilities:

• Independently manage budgetary responsibilities and research contracts for clinical research faculty members
• Analyze, forecast and develop annual budget for clinical researchers
• Track budget for federal and non-federal grants, development funds and clinical trial studies
• Develop, negotiate and maintain contract administration
• Ensure adherence to budgets and provide written report defining budget variances
• Report any significant budget variances as they are identified
• Prepare financial statements, reports and compliance audits
• Manage all grant researchers
• Manage tracking and monitoring of all direct and indirect costs for all grants/clinical trials in accordance with funding agencies
• Oversee expense reconciliation of all grants and development funds
• Prepare monthly status reports
• Manage data entry of all expenses, payroll, etc. for all grants/clinical trials
• Audit and review accounts throughout the year to ensure compliance with the NIH and prepare monthly variance analysis reports and track CME expenditures
• Manages staff supporting Clinical Trials/ Research activities for the department.
• Recruit, interview, train and supervise research staff, students and others involved with research protocols.
• Coordinate, assign and review work of others as it relates to research studies.
• Manage all personnel, records and work study student contracts.
• Oversee implementation of reports for personnel and investigator funding
• Manage space & facilities planning for the group.
• Project Management and Clinical Trials/Research Activities Coordination
• Serve as liaison between the IRB and the department, obtaining necessary approvals for research projects
• May work other departments to develop and implement programs in support of the clinical trials/ research activities.
• Research and analyze project components.
• Provide instruction on research protocols including interpretation of test results, observations, and related study data to physicians, nurses, professors, teachers, and technician involved.
• Coordinate registration/travel accommodations and travel reimbursements as requested.
• Coordinate travel and speaking arrangements with outside institutions as requested.

TECHNICAL CAPABILITIES:

RESEARCH ADMINISTRATION (EXPERT): Knowledgeable on all phases in the lifecycle of a sponsored research project. Well versed in and able to assist researchers in reducing compliance risks and assisting in routine and specialized processes.

MEDICAL RECORDS MANAGEMENT (EXPERT): Knowledge of how and where to store and maintain basic records associated with job assignments.

LABORATORY PRACTICES (EXPERT): Is a recognized expert and authority in laboratory practices. Occupies the position that is the last internal resource for support or direction. Expected, as a result of the position, to have the ultimate knowledge, control, influence, and/or jurisdiction in laboratory practices. Demonstrates industry leadership in outside professional organizations and forums. Takes a lead role in developing best practices for the organization.

CORE ACCOUNTABILITIES:

• Organizational Impact: Directs activities to achieve operational plans with some near term effect on results of the department/area.
• Problem Solving/ Complexity of work: Identifies issues, gathers facts to resolve technical and operational problems.
• Breadth of Knowledge: Applies in-depth knowledge and skills of a professional/technical area and basic management knowledge to manage the work of the team.
• Team Interaction: Leads a complex department with a focus on implementation. Typically executes on a short to medium term strategies.

CORE CAPABILITIES:

SUPPORTING COLLEAGUES:

• Develops Self and Others: Invests time, energy and enthusiasm in developing self/others to help improve performance and gain knowledge in new areas.
• Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships.
• Communicates Effectively: Recognizes group interactions and modifies one's own communication style to suit different situations and audiences.

DELIVERING EXCELLENT SERVICES:

• Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them.
• Solves Complex Problems: Approaches problems from different angles; Identifies new possibilities to interpret opportunities and develop concrete solutions.
• Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees' effectiveness.

ENSURING HIGH QUALITY:

• Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly.
• Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them.
• Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring.

MANAGING RESOURCES EFFECTIVELY:

• Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure.
• Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area.
• Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities.

FOSTERING INNOVATION:

• Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches.
• Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges.
• Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements.