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The Director of Oncology and Pediatric Clinical Research Operations (the “Director”) is a member of the Senior Research Leadership team who, under the guidance of the Executive Director, is accountable for providing strategic planning, financial forecasts and establishing/maintaining the research infrastructure and activities of the AHRI cancer and pediatric Clinical Research Offices. The Director is accountable for the staffing, operations, research integrity, and financial performance of basic, translational and clinical research conducted at all identified Central Florida Division locations.
The Director provides expertise, guidance and oversight to the managers and supervisors assigned to these areas and establishes and implements operational standards and best practices to ensure consistent, safe and efficient management of clinical trials and fiscal integrity of the clinical research activities.
The Director interacts and collaborates frequently with physician leadership, senior leaders, managers, key external partners including the Moffitt Cancer Center, on strategies to improve research operations and performance pursuant with AdventHealth goals and requirements. The Director fosters positive working relationships with industry representatives, physician investigators and others and effectively communicates AdventHealth initiatives and priorities. S/he actively participates in outstanding customer service and accepts responsibility to ensure relationships are equally respectful to all.
PRINCIPAL DUTIES AND JOB RESPONSIBILITIES:
• Accountable for the executive administrative direction and management, implementation and execution of clinical research operations, including participant recruitment, patient-facing operations, data capture and integrity, that meet the needs of the hospital, Cancer Institute and patients served.
• Works alongside the Scientific Directors, Institute Leadership and research executives to operationalize new and existing research programs and initiatives. Contributes to the scientific and operational review of projects and assessment of accrual feasibility in order to make decision for which projects to accept and move forward.
• Prioritizes research initiatives, identifies new funding mechanisms and supports investigators and directs staff in the preparation of grant applications.
• Actively manages Clinical trial portfolio and provides direction and leadership to accelerate clinical trial startup by reducing budget, Medicare Coverage Analysis and Pharmaceutical company cycle times on all contract and budget negotiations. • Works closely with the AdventHealth Foundation to procure philanthropic funding for various projects, and with the Medical Director to lead the development of new multi-PI team science grants, capitalizing on strong clinical trials and large patient volumes. • Represents Adult and Pediatric Oncology, Neonatal and Pediatric research investigators and teams on research and hospital committees; participates in task forces related to network clinical trial activities in NCI-designated comprehensive cancer centers, and serves as a liaison at the state and federal level to advance clinical research interests as well as community outreach.
• Accountable for meeting research participant recruitment performance metrics through the provision of direction and management of Clinical Research Operations Mangers and Study Intake, Program Managers.
• Fosters collaborative working relationships with cross-functional executive leaders (i.e., finance, legal, and regulatory, others) in order to align processes, maximize efficiency, and drive timely and quality project delivery. • The Director will also formulate, implement, and interpret policies specifically related to regulatory operations in conjunction with Cancer Center Support Grant (CCSG) guidelines; • Ensures direct reports submit high quality, accurate and timely data packages into information systems (e.g., CTMS, clinical trial databases, EPIC EMR and other tracking systems) that generate operations, financial, NCI, regulatory and other leadership reports. • Responsible for the development of Oncology and Pediatric research annual operating budgets, including the determination of AdventHealth foundation and clinical trial-related revenue projections. • Responsible for on-budget expense projections including staffing, study-related activity, supplies, capital and operational expenditures that meet the needs of the investigators and trials in the portfolio. • Performs long- and short-range financial, strategic and business planning. • Plans and manages AHRI activities to ensure adherence to funding and membership goals/objectives to ensure NCI Cancer Center designation is obtained/maintained (e.g., data tables, accrual of women, minorities and children to clinical trials, etc.).
• Creates the structure, culture and standards for implementing steps and corrective action plans, as necessary, to maintain safe and compliant delivery of care for all research participants.
• Ensures Oncology and Pediatric research teams develop and maintain standard and administrative operating procedures (SOPs) and other business-related tools. • Accountable for the recruitment, supervision, performance management and evaluation (including progressive disciplinary measures) of subordinate managers, supervisors, and staff.
• Determines appropriate staff workloads and staff complements to effectively accomplish the department’s goals and objectives.
• Fosters open and clear communications between the research office, AdventHealth physician investigators, clinical and research laboratory, investigational drug services and clinical personnel including infusion, outpatient and inpatient clinical teams.
• Promotes and maintains organizational efficiency and effectiveness. Defines and measures accrual and other performance metrics and provides executive leadership with regular status updates on productivity, progress of the trials and alliances; and identifies opportunities of risk and/or improvement.
• Communicates and openly supports new policies and procedures and strategic/tactical priorities as outlined by the Executive Director, Office of Research Integrity and other AdventHealth research initiatives.
• Collaborates with Research Services, the Office of Research Integrity, Institute Development and Executive leadership to ensure strategic alignment of research activities and processes across the enterprise.
• Organizes, conducts and participates in internal and external meetings, including NCI administrative leadership meetings, as needed to maintain relationships and collaborations with affiliate hospitals, partnerships and research sites. Serves as primary point of contact for Clinical Research Unit and Clinical Trials Unit Operations, with Moffitt Cancer Center counterparts.
• Promotes AdventHealth research capabilities at local/national meetings and educational conferences pertinent to public relations and future business opportunities
• Maintains up-to-date knowledge of scientific and clinical literature in relevant therapeutic areas including key clinical development topics. • Maintains a positive work climate; applies policies fairly and consistently and fosters an environment where employees contribute to the organization
KNOWLEDGE AND SKILLS REQUIRED:
• Demonstrated expertise in leading multi-site, early and late phase clinical research operations and working knowledge of National Cancer Institute Cancer (NCI) Center Support Grant (CCSG) requirements.
• Highly knowledgeable about clinical research with specific knowledge in the areas of NCI CCSG expectations and expanding research operations to new clinical sites, including early phase sites. • Extensive knowledge of clinical research concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials (FDA, IRB, NCI and National Institutes of Health (NIH guidelines).
• Exceptional strategic leadership and team building skills with proven ability to harmonize interests of investigators, staff, executive leadership and other internal and external stakeholders
• Experience in increasing efficiencies and decreasing timelines in the submission, scientific review, and execution of grants and protocols to ensure processes are performed with limited redundancies and in the least burdensome manner.
• Demonstrated proficiencies in cost-containment measures and the ability to create an atmosphere which encourages this practice
• Working knowledge of Medicare Coverage Analysis (MCA) processes, developing and negotiating clinical study and departmental budgets.
• Ability to lead, delegate, accept responsibility, exercise authority and function independently.
• Excellent organizational, analytical, quality improvement and problem-solving skills.
• Strong analytic and problem-solving skills to evaluate situations and make appropriate and timely decisions.
• Effective oral and write communication skills with the ability to articulate complex information in understandable terms to all levels.
• Advanced computer skills, including Microsoft Office (including Teams virtual meetings) and clinical trial management systems.
KNOWLEDGE AND SKILLS PREFERRED:
• EPIC EMR, BioOptronics Clinical Conductor, Florence e-Binders and SmartSheet
EDUCATION AND EXPERIENCE REQUIRED: • Bachelors’ Degree required; Advanced degree in Business or Research Administration or other relevant Healthcare fields preferred • 7+ years of oncology clinical research experience • 5+ years’ progressive management experience; preferably in an academic environment or NCI designated cancer center
• Previous experience coordinating and managing multi-site clinical research programs
LICENSURE, CERTIFICATION OR REGISTRATION PREFERRED:
• ACRP, SoCRA or OCN certification eligible; certification preferred
• Responsible for the oversight of all clinical research staff, including Clinical Research Operations managers, supervisors, Study Intake Program managers, research support assistants and clinical research coordinators.
• Ensures that job descriptions and performance standards are established for all levels of staff and that effective performance and disciplinary management guidelines are adhered to in accordance with AdventHealth guidelines.
• Interviews, hires, disciplines, evaluates and terminates research employees according to AdventHealth guidelines.
• Sets clear, compelling goals for the staff and monitors productivity and output for research personnel.