Director, Clinical Research

Director, Clinical Research

Job No: 525482
Work Type:
Location: Main Campus (Gainesville, FL)
Categories: RealCat
Department: 29011700 - MD-OFFICE OF RESEARCH

Job Description


Classification Title:

Director, Clinical Research

Job Description:

The Office of Research at the University of Florida 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.

The Director of Clinical Research will direct the research, administrative and evaluation activities of clinical research within UF Health. In conjunction with the Senior Associate Dean for Research in the College of Medicine and other senior leaders, this position is directly responsible for the 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. The incumbent provides 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. The incumbent 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.

Programmatic:

• Enhance the perception of the UF Office of Clinical Research amongst UF investigators and industry and federal sponsors accomplished through actively developing strong collaborations with internal organizations and physician teams and through discussing and demonstrating to sponsors the enhanced capabilities of UF to facilitate their studies with quantifiable and quality data.
• 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 full implementation of the OnCore clinical trial management system (CTMS) through creating accountability with study coordinators for input. Implementation of OnCore will also require extensive collaboration with UF Academic Health Center IT (AHC IT) staff members, and maintain a strong business relationship with the software's vendor Forte Research.
• Develop effective collaborations with CTSI, the UF Health Research Coordinators Consortium, IRB, relevant Centers and Institutes 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 within the OnCore CTMS platform.

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 trials established at the UF OCR. 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 UF OCR. 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 OCR functions.

Compliance:

• Coordinate monthly OCR/IRB/CTSI discussions with 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 all regulatory requirements (FDA, GCP, ICH). Responsible for regulatory compliance at all levels. Performs other responsibilities as required.
• Oversight of all training and development of OCR staff. Collaborates with UF Health and the CTSI Translational Workforce Development program to develop educational opportunities for all UF research staff.
• 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).

Operations:

• Prepares operational reports and assists in providing specific education and training. Responsible for direct oversight and supervision of the OCR Leadership team.
• Ensures compliance with all applicable regulations for the conduct of clinical research and adherence to Good Clinical Practice.
• Ensures the use of OnCore in daily operations of OCR. Integrates processes to ensure subject data in OnCore 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 grant application.
• Oversight of initial and ongoing training process of staff. Perform regular performance reviews of OCR processes. Helps develop specific minimum learning standards/requirements for Clinical Coordinators and physician-investigators.

Misc duties as assigned.

Expected Salary:

Commensurate with education and experience.

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:

Applicants should include a letter indicating their interest, curriculum vitae (CV), and a list of at least three professional references.

The University of Florida 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.

This is a time limited position.

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

Health Assessment Required:
No



Advertised Salary:

Minimum Requirements
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Preferred Qualifications
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Special Instructions to Applicants
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Health Assessment Required: $Health

Applications Close: $Closes

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

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. jeid-f10d989d4e14c54ebae8d78494ae2373