Assistant Director of Clinical Research - Clinical Research Hub

Assistant Director of Clinical Research

Masters degree in appropriate area of specialization and two years of appropriate experience; or a bachelors degree in appropriate areas of specialization and four years of experience.

The Office of Research in the College of Medicine is seeking an Assistant Director of Clinical Research to help lead in the colleges 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 Assistant Director of Clinical Research is a key leader in the success of UF Healths 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. The day-to-day this role will direct the research administrative and evaluation activities of the Clinical Research Hub (CRH) in the COM Office of conjunction with the Director of the Clinical Research Hub Assistant Dean for Clinical Research the Senior Associate Dean for Research in the College of Medicine Director of Research Strategy and Operations this position is responsible for the day-to-day oversight and coordination of the clinical research tasks within the College of Medicine and UF Health. The incumbent provides advice and guidance to faculty clinicians and management of all clinical research personnel task activity to include the oversight and development of training initiatives audit manuals and standard operating procedures.

About This Role:

• 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.
• Partner with the Director of the Clinical Research Hub Assistant Dean of Clinical Research and the Senior Associate Dean for Research 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.
• Oversees the success of the enterprises operation maintenance and development of the clinical trial
  management system (CTMS). Recruitment and retention of appropriately skilled staff to development
  implement and conduct appropriate training and education for users.
• Develop effective collaborations with Centers Institute large thematic program investigators and
  directors study coordinators IRB and other key stakeholders.

• Responsible for the day-to-day oversight and supervision of the CRH and its staff. Manage crossfunctional team resources and external service providers to conduct clinical research on time.
• In partnership with internal and external service providers develop best practices methods techniques and operational standards for clinical research across the enterprise.
• Responsible for managing assigned portfolio maintaining protocol records building billing grids and managing CRH workflows within the CTMS and being a navigator with Advarra.
• Responsible for understanding and implementing functions of CTMS. Responsible for the mitigation and/or corrections to approved MCA and/or billing compliance reviews assigned. Serves as the point of contact for assigned portfolio for all CAB assigned duties. Ensure proper functionality of the assigned portfolio in the CTMS. Serve as a resource for basic compliance inquiries and maintain consistent communications between CRH staff UF research units and external stakeholders through the CTMS and other communication platforms.
• 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).

• 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.
• Serve as the subject matter expert and point of contact for CRH QA team functions relevant to the projects under the purview of CRH.

• 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.
• Oversight of appropriate regulatory requirements (FDA GCP ICH) and regulatory compliance
• 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.

• 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.

$112000 - $125000; commensurate with education and experience.

Masters degree in appropriate area of specialization and two years of appropriate experience; or a bachelors degree in appropriate areas of specialization and four years of experience.

• Six years experience in working with clinical trials management software.
• Extensive 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.
• Six years or more of experience in clinical research administration and/or financial management in an academic/medical setting.
• Strong familiarity with the OnCore CTMS by Advarra.
• Strong Ability to work with detailed data and information understand various reporting/tracking tools and interpret and apply the data and information.
• Strong Ability to balance customer service and research compliance.
• Strong Ability to independently and collaboratively organize and work effectively prioritize be flexible and stay on task in a high-paced high-volume professional environment.
• Strong oral and written communication skills.
• Strong ability to analyze complex situations identify workable solutions/alternatives and make appropriate recommendations that consider the competing needs and priorities of various stakeholders.
• Strong ability to develop and maintain effective working relationships in a diverse and multilayered team environment.
• Skilled in problem solving techniques critical thinking and creativity and possess aptitude to develop new solutions.
• Strong ability to assess assist confirm educate and monitor user expectations and satisfaction.
• Strong time management organizational documentation attention to detail and task follow up skills.
• Demonstrated ability navigating complex trials. History of solving problems while exhibiting superior judgement and a balanced realistic understanding of issues.

In order to be considered you must upload your cover letter and resume.

This is a time-limited position.

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