POSITION SUMMARY: The Executive Director of Research Administration is a highly visible position that leads and oversees the Penn Medicine Lancaster General Health (PMLGH) Research Program and administration. The role, in collaboration with research leadership, develops and sets strategic and administrative goals, policies and procedures relating to the research program. This includes research financial administration, research compliance, and research support services. This highly collaborative role establishes and optimizes, relationships with the University of Pennsylvania and other research partners and relationships with research entities within PMLGH, as well as chairing the Research Council. The Executive Director of Research Administration is also responsible for establishing research training, education, and quality standards while facilitating development of new research investigators.
ESSENTIAL FUNCTIONS: Qualified individuals must have the ability (with or without reasonable accommodation) to perform the following duties:
Serves as the external and internal “face” of the PMLGH Research Program.
Helps to identify new research opportunities that are aligned with the research strategic plan and the overall Penn Medicine Lancaster General Health mission.
Responsible for the promotion and advancement of the research program and fostering an environment of quality, compliance, and efficiency.
Develops, sets, and executes the research program priorities and strategic vision.
Monitors the performance, compliance, operation, and viability of the research program at PMLGH and its entities.
Oversees, directs, and ensures high performance and compliance for the Research Program. Fosters an environment of trust, compliance, open communication and professionalism throughout the PMLGH research program.
Oversees Research Integrity Program , HRPP manager and IRB Coordinator and any associated administrative functions or support for the IRB.
Provides oversight and leadership for Biostatistics and Data Management, Research Operations, Support, and Finance, Research training, education, and quality initiatives, Research pre-award, post-award, grants, and clinical trial administration, Clinical research Investigator, Coordinator and Research Nurse support services, EPIC and CTMS integration and ongoing function for research, Research financial administration and accounting functions and research support services.
Regularly interacts with Penn Medicine Lancaster General Health leadership, physicians, investigators, patients, administration, federal research sponsors, industry research sponsors, nurses, coordinators, and other support personnel.
Develops research program business processes that allow PMLGH conduct research efficiently and compliantly.
In collaboration with Research and administrative leadership, develops annual goals to include the strategic plan for research institute, annual process improvement plan, and research staff coaching and development plan.
Responsible for ensuring the financial viability of the research program.
Oversees the development of Research Institute personnel both administratively and clinically to allow PMLGH to effectively manage research.
Partners and collaborates with the PMLGH Compliance Office and Legal Department to educate, evaluate, and address research compliance issues and risks.
Partners with executive and physician leadership of ABBCI CRU to support growth, development, and compliance of cancer research trials.
Ensures critical research business processes are operating properly and identify ways to continually enhance their compliance, functionality, and performance.
Ensures the research program serves the needs of patients, investigators, and the health system.
Oversees and directs the promotion of the research program through advertising, marketing, publication, and other means.
MINIMUM REQUIRED QUALIFICATIONS:
Bachelors degree required in a health related field.
Minimum of ten (10) years of experience in a research environment, with at least five (5) years at the manager level or above
Experienced in clinical trial and study operations, federally funded grants, research financial administration, human subjects protection, and research compliance.
Experience working with research patients, communicating with physician investigators and clinical staff, and understanding the work dynamic of conducting research in a hospital.
Understanding of hospital patient billing, charge capture and revenue cycle operations.
Substantial knowledge of FDA Good Clinical Practices, OMB Circular A-110, A-122, and A-133, OHRP and AAHRPP guidance, 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR Part 46, and other applicable research regulation.
Demonstrated leadership ability and execution of office or program objectives.
Experience developing and executing a strategic plan.
Experience dealing with physician investigators and encouraging their participation in the research program.
Strong communication, interpersonal, and team building skills.
Strong computer, word processing, presentation and spreadsheet skills.
Flexibility and comfort in working within ambiguity and fast paced environments.
The ideal candidate will have 8+ years of experience in managing clinical trials and federally funded research.
Advanced degree (MD, MBA, MPH, MSN, JD, PhD, or similar) in a health related field.
Experience generating philanthropic and grant support.
Experience working with or for, an academic medical center.
Familiarity with clinical research, IRB and grant accounting technology.