POSITION SUMMARY: Responsible for administration of the Human Research Protection Program (HRPP) and accreditation, management of the Institutional Review Board (IRB) functions and processes, and HRPP quality assurance activities throughout LG Health. Interacts with investigators, coordinators, IRB members, regulatory and other staff regarding research training, HRPP requirements and resources, and monitoring.
ESSENTIAL FUNCTIONS: Qualified individuals must have the ability (with or without reasonable accommodation) to perform the following duties:
Manages the Institutional Review Board (IRB) administrative functions, staff, operations and data management.
Oversees use and customization of IRB management system. Generates reports and performance metrics from IRB management system.
Serves as first-line resource to investigators wanting to conduct research; navigates investigators through the IRB requirements/submission process, counsels on human subject protections and research quality.
Organizes regular meetings of the HRPP leadership group, develops meeting agenda and materials, takes and distributes minutes.
Gathers input on HRPP policies, drafts revisions, brings revisions to the HRPP leadership group for approval, and makes updates to the posted HRPP policy manual.
Manages creation of annual reports and required status reports for AAHRPP accreditation.
Leads HRPP in formal evaluation process required for accreditation.
Coordinates application efforts for re-accreditation process.
Manages the training and education activities of the human subject protection program; tracks certification of research personnel.
Manages research-related conflict of interest disclosure for the human subject protection program; tracks completion of required disclosure documents.
Manages the monitoring activities of the human subjects protection program; conducts on-site reviews of LG Health research studies for compliance with institutional policies and procedures and generates reports.
Reports on monitoring, training and education, and conflict of interest disclosure to the IRB and/or the Research Compliance Committee as required.
Manages applications for renewal of human subject protection program accreditation.
MINIMUM REQUIRED QUALIFICATIONS:
Master’s degree in a business, science, public health or related area is preferred.
Bachelor’s degree in a business, science, public health or related area is required.
5 years of experience in field of clinical research or related area within healthcare.
Experience with HRPP/IRB administration, regulatory and HRPP accreditation.
Proficient computer skills and demonstrated application of those skills relative to job experience in database design, software/system administration, spreadsheet, word-processing and multimedia applications.
Three years experience in research, quality assurance or performance improvement preferred.
One year experience in software/database administration preferred.
Lancaster General Health (LG Health), a member of the University of Pennsylvania Health System (Penn Medicine), is a 631-licensed bed not-for-profit health system with a comprehensive network of care encompassing Lancaster General Hospital (LGH), Women & Babies Hospital and the Lancaster Rehabilitation Hospital (in partnership with Kindred Healthcare). Our membership in Penn Medicine brings togeth...er the strengths of a world-renowned, not-for-profit academic medical center and a nationally recognized, not-for-profit community healthcare system.