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Posted Job Title

Job Profile Title
Associate Director, Clinical Research Quality

Job Description Summary
The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of
cancer. The ACC Clinical Research Unit (CRU) is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. The ACC CRU is currently
comprised of 12 Research Teams that support disease/discipline specific cancer programs within the ACC. Reporting to the Director of Clinical Research Operations for the ACC CRU, the Associate
Director of Education and Quality Assurance will be responsible for the overall education and training program for the ACC CRU Clinical Research Professionals (CRPs) and investigators to support
the conduct of cancer clinical trials, and is responsible for the day to day quality assurance oversight that is aligned with ICH Good Clinical Practice (GCP) to ensure ACC CRU inspection
readiness comply with the requirements of the University of Pennsylvania, FDA, and all applicable regulatory bodies. The candidate must have a thorough knowledge of ICH-GCP regulations and
comprehensive understanding of clinical trial processes, and the conduct of clinical research studies.

Job Description

Job Responsibilities

The candidate will direct the planning, design, preparation and delivery of comprehensive clinical research training and development programs for ACC CRU CRPs and investigators. The candidate is
responsible for evaluating and enhancing CRP and investigator learning, continuing education, development, and growth.

• Direct comprehensive orientation and training programs for ACC CRU CRPs including program managers, clinical research nurses, clinical research nurse practitioners, clinical research
  coordinators, biospecimen coordinators, and research assistants. Direct oversight of a training needs analysis to determine specific training needs for CRPs. With the assistance of the CRU
  Education and Training Program Manager, the candidate will train new CRPs to independently to conduct Phase I – IV complex clinical trials, including consenting, screening and enrolling
  subjects after ensuring eligibility, managing subjects‘ treatment per protocol, collecting and reporting research data, serious adverse event reporting per protocol and institutional
  requirements, and ensuring adherence to protocol requirements. The candidate will develop tools and assessments to ensure effective training of new hires and reduce time to proficiency and
  create and maintain a system to document CRP training to ensure comprehensiveness and quality of training.
• Direct ongoing training, continuing education, development and growth for CRU CRPs and investigators. Identify, select, and/or develop appropriate training programs, including the selection
  or design of appropriate training aids
• Lead in-service training for ACC CRU CRPs and communicate ongoing training opportunities and continuing education training programs available within the University of Pennsylvania and in
  the Research Community to further advance these initiatives.
• Directly manage and supervise the ACC CRU Education and Training Program Manager, including performance management and overseeing the hiring process when needed. Assess the need for
  additional CRPs for Education and Training and develop plans for hiring additional CRPs as needed in conjunction with the ACC CRU Director of Clinical Research Operations and the CRU Medical
  Director.

The candidate will develop and maintain an internal quality assurance and improvement program for the CRU to enhance the conduct of CRU clinical trials to ensure adherence to all University of
Pennsylvania, FDA and GCP guidelines. In conjunction with ACC Regulatory, the candidate will direct the preparation, and daily workflow for ACC CRU external inspections by the FDA, EMA, and
NCTN/Cooperative Groups.

• Develop a program to continually assess protocol compliance and data quality across the CRU research teams and prepare reports for the ACC CRU Director of Clinical Research Operations and
  the Lead Physician Investigator for each research team.
• Develop process improvements and guidance documents to ensure adherence to standard operating procedures, GCP, and requirements of all applicable regulatory bodies, increase unit
  efficiency, and reduce errors.
• Conduct regular internal reviews of CRU trials including review of institutional internal audits (i.e. ACC and OCR) to identify problems with protocol compliance, patient safety, and data
  integrity. Report findings to study PI, Lead Physician Investigator for the Research Team, ACC CRU Medical Director and ACC CRU Director of Clinical Research Operations. Review and content
  editing recommendations for all internal & external audit responses.
• Create ACC CRU-wide corrective actions and develop training related to research compliance, quality control and quality assurance. Assist Principal Investigators and Research Team Program
  Managers/ Lead Clinical Research Nurses in developing corrective action plans for study-specific deviations.
• Develop a program to assist research teams with improving data integrity and documentation. Assess the need for additional CRPs for Quality Improvement and develop plans for hiring
  additional CRPs as needed in conjunction with the ACC CRU Director of Clinical Research Operations and the ACC CRU Medical Director.
• Collaborate with the ACC CRU AD of Clinical Research Operations, the ACC CRU Director of Clinical Research Operations and the ACC CRU Medical Director with unit-wide guidance documents and
  work instructions to enhance processes.
• Interview candidates, check references and make hiring recommendations to the ACC CRU Research Teams as requested.

Qualifications

• Master of Science, Master of Arts, and 5 to 7 years of experience or equivalent combination of education and experience is required. Training and experience in clinical research or clinical
  research compliance healthcare required. At least 5 years‘ experience in a hospital, academic medical setting, or pharmaceutical industry with principal responsibilities related to clinical
  research and or research education preferred. Oncology experience preferred.
• An in-depth knowledge and experience in the application of the relevant regulations for the conduct of clinical research including International Conference of Harmonization (ICH) Good
  Clinical Practice (GCP) and FDA Title 21 Code of Federal Regulations (CFR) requirements. Knowledge of IRB and human research protection regulations. Ability to interpret regulations and
  disseminate information is desired.
• Supervisory experience and/or managing teams preferred.
• Able to confidently interact with all levels of management including senior management, physician leaders and other collaborators.
• Demonstrated ability to work collaboratively on all levels and to gain support of others.
• Experience developing and implementing policy or procedural documentation and training tools preferred.
• Experience with FDA/federal agency inspections preferred.
• Familiarity with the essential documents related to clinical studies, medical terminology and routine medical tests and procedures. Familiarity with computerized clinical data collection
  systems is preferred.
• Must be detail oriented and organized. Strong planning, time management, and organizational skills along with attention to detail, excellent follow-through, and problem-solving skills
  necessary.
• Excellent interpersonal communication and writing skills required. Strong MS Office skills.
• Must be effective in setting and meeting personal short and long-term goals to complete assignments, with multiple project tasks ongoing simultaneously.
• Excellent technical writing, review, and strong analytical abilities.