Director of Clinical Research - Office of Research, College of Medicine

Director of Clinical Research - Office of Research, College of Medicine

Job No: 525482
Work Type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Executive/Director/Management, Grant or Research Administration
Department: 29011700 - MD-OFFICE OF RESEARCH

Job Description

Classification Title:

Director, Clinical Research

Job Description:

The Office of Research in the College of Medicine is seeking a Director of Clinical Research to help lead in the college's strategic development of a data-driven transparent and sustainable research enterprise that is investigator-focused and powered with artificial intelligence and cutting-edge technologies.

As the Director of the Clinical Research Hub, you will be a key leader in the success of UF Health's clinical research portfolio, tasked with delivering operational excellence, maintaining and improving the infrastructure, processes and systems necessary to support scaling efficient, safe, and high-quality clinical research in the College of Medicine and in UF Health. Day-to-day, you will direct the research, administrative and evaluation activities of the Clinical Research Hub (CRH) in the COM Office of Research. In conjunction with the Senior Associate Dean for Research in the College of Medicine and other senior leaders, you will be responsible for oversight and coordination of study development, implementation of clinical research, data collection, strategic planning, administrative oversight, regulatory activities and team management for clinical research operations within the College of Medicine and UF Health. You will provide advice and guidance to faculty clinicians, and management of all clinical research personnel activity, to include the oversight and development of training initiatives, audit manuals, and standard operating procedures. You will formulate and implement ongoing, programmatic, strategic, compliance and operations-oriented improvements, evaluate and develop metrics and benchmarks for trial conduct, monitor study progress, and will develops/implements strategic processes for optimal efficiency and outcomes.

As a successful candidate, you will be an experienced clinical research site operator (multi-site) and leader willing to stretch into new and different tasks as the business requires. The ideal candidate will have direct experience in trial operations, a proven track record leading a multi-site operation with P&L responsibility, deep understanding of clinical research compliance, quality and regulatory issues, a strategic mindset, and a passion for engaging with researchers and clinicians to collaborate in a model of excellence in clinical research operations.

Programmatic:

• Participate as a key leader in strategic growth, enhancements, and rise in the rankings of the COM and UF' Health's clinical research enterprise
• Foster the research enterprise by actively developing strong collaborations with internal programs, directors, faculty and clinician teams and through discussing and demonstrating to sponsors the enhanced capabilities of UF and UF Health to facilitate their studies with quantifiable and quality data.
• Partner with COM and UF Health leadership to educate investigators, clinicians and research/clinical staff on ongoing research activities, participation opportunities, and to train on operational best practices and workflows
• Implement continuous process improvement across all trial types. Process improvement can be related to but is not limited to: trial implementation flow, timing of trial implementation, coordination of staff tasking and workload analysis, streamlined project assignment and delegation procedures, creation of staff accountability and performance evaluation through process improvement. Results of process improvement should be well documented and disseminated to staff and vested institutional stakeholders through standard operating procedures.
• Oversee the enterprise's operation, maintenance, and development of the clinical trial management system (CTMS). Ensuring appropriate training and education for users, ensure accountability with study teams for input. The operation of the CTMS will also require extensive collaboration with UF Academic Health Center IT (AHC-IT) staff members, and maintain a strong business relationship with the software vendor.
• Develop effective collaborations with Centers, Institute, large thematic program investigators and directors, study coordinators, IRB, and other key stakeholders.
• Operationalize and manage the data collection, archival and reporting of clinical trials metrics for the UF clinical research enterprise (both UFHCC and AHC managed protocols). This is to be accomplished by establishing relationships, data collection methodologies, data validation, and the implementation of reporting technologies.

Strategy:

• Develop and implement strategic methods to approach the enhancement of patient enrollment figures. Evaluate the impact of these methods on patient enrollment through cost verses return analysis and return on investment metrics. Establishing goals, both internal and external that facilitate the progression to successfully accomplishing this directive.
• Focus on the growth in number of equitable projects and trials established at the CRH. Determine methods for analyzing and tracking the workload requirements by trial type and the capacity staffing provides to effectively manage and service active, inactive, and closed trials.
• Focus on the growth in number of equitable trials established at the CRH. Determine methods for analyzing and tracking the workload requirements by trial type and the capacity staffing provides to effectively manage and service active, inactive, and closed trials.
• Prepare periodic reports documenting performance of critical CRH functions.

Operations:

• Responsible for the direct oversight and supervision of the CRH and its staff. Manage cross-functional team resources and external service providers to conduct clinical research on time, on budget, in compliance, and of highest quality
• In partnership with internal and external service providers, develop best practices, methods, techniques, and operational standards for clinical research across the enterprise.
• Provide direction and oversight of quality and risk management activities, including identification, tracking, and investigation of potential issues, compliance with existing policies and procedures, regulations, standards, and guidelines, and development/monitoring of risk mitigation plans as necessary.
• Perform/manage internal audits to ensure adherence to quality standards, operational best practices, and to identify potential risks to trial performance or patient safety; report related deficiencies and associated risks to senior leadership as well as plans for risk mitigation and corrective and/or preventive actions (CAPA).
• Ensures the use of the CTMS in daily operations of CRH. Integrates processes to ensure subject data in the CTMS are updated in a timely manner.
• Establish, manage and maintain strict data reporting requirements for all clinical trials, including cancer related clinical trials on campus to incorporate the data into the required reporting standards and tables for the NCATS, CTSI, and NCI, CCSG, P30, and other grant applications.
• Responsible for delivery of reporting, dashboards, and insights (weekly, monthly) to users, internal stakeholders, and leadership
• Manage communication of priorities to ensure execution of goals and milestones through regular meetings, status updates, and other written communications
• Oversight of initial and ongoing training process of staff. Perform regular performance reviews of CRH workflows, processes, and customer service. Helps develop and inform on specific minimum learning standards/requirements for Clinical Coordinators and clinician-investigators.

Compliance:

• Coordinate monthly stakeholder (i.e. IRB/CRH, Shands/CRH) discussions with leadership, staff and related institutional parties. Discussion should include outstanding process issues, existing trial or trials in route to opening and complications developed, root cause analysis/discussion/resolution, development of institutional streamlining SOPs. The end goal of these discussions should be shortening the time to opening trials and mitigating/reducing the number of errors in protocol and trial documentation submissions.
• Oversight of appropriate regulatory requirements (FDA, GCP, ICH) and regulatory compliance Performs other responsibilities as required.
• Oversight of all training and development of CRH staff. Collaborates with UF Health, UF Research, and the CTSI Translational Workforce Development program to develop educational opportunities for research staff operating in UF Health.
• Oversight of the development, implementation and maintenance of SOPs to ensure timely reporting of adverse events, serious adverse events and unanticipated problems to the Data Safety Monitoring Committee (DSMC).
• Train, develop, and mentor leaders within the organization to ensure succession planning for key positions (including this one)

Academic:

• Engage in routine personal and professional development to stay abreast of relevant topics related to the position.
• Participate in committees and workgroups, academic literature, etc. related to clinical trials, clinical operations, recruitment and retention

The City of Gainesville

Gainesville is a vibrant city with a low cost of living, diverse population, excellent public schools, Division I NCAA sports, and no state income tax. The area is known for its nature parks, bike trails, sporting events, museums, mild winters, and warm summers. Being centrally located makes Gainesville easily situated for day trip to beautiful beaches along the Atlantic Ocean and Gulf of Mexico, and to theme parks including Disney World, and other cities include Orlando, Jacksonville, and Tampa. Learn more about what Gainesville has to offer at Visit Gainesville.

Our Commitment

The University of Florida College of Medicine is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

Expected Salary:

Commensurate with education and experience.

This position is eligible for great benefits, including health, dental, and vision insurance plans, retirement plans, and paid time off

Minimum Requirements:

Master's degree in an appropriate area and six years of relevant experience; or a bachelor's degree in an appropriate area and eight years of relevant experience.

Preferred Qualifications:

• PhD, MSN, MBA, MHA or associated Clinical Research Related Degree.
• Two years' experience in working within and/or conducting pragmatic, observational, and community-based health care projects.
• In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale.
• Familiarity with concepts of clinical research and clinical trial design
• Sound scientific and clinical judgement- knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements.
• Ability to effectively present ideas and document complex concepts as they relate to clinical trials in both written and oral communication
• Demonstrated ability as a director of clinical trials in a complex matrix environment. History of solving problems while exhibiting superior judgement and a balanced, realistic understanding of issues.

Special Instructions to Applicants:

To apply, please complete the online application and attach a letter indicating their interest, curriculum vitae (CV), and a list of at least three professional references.

If an accommodation due to a disability is needed to apply for this position, please call 352-392-2477 or the Florida Relay System at 800-955-8771 (TDD). Hiring is contingent upon eligibility to work in the US. Searches are conducted in accordance with Florida's Sunshine Law.

This is a time limited position. This requisition has been reposted with additional information. Previous applicants remain under consideration and need not apply.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required:
No

Applications Close: 04 Jun 2023

To apply, visit https://explore.jobs.ufl.edu/en-us/job/525482/director-of-clinical-research-office-of-research-college-of-medicine

The University is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

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