PRIMARY FUNCTION:

With the direction of the VP/Physician Leader for Research Administration and Scientific Affairs, to assure the protection of human research subjects ; plan, coordinate and direct the activities of the Institutional Review Boards of Christiana Care; collaboratively oversee the conduct of research at all Christiana Care sites of care; this includes oversight of research conduct at multi state Community Clinical Oncology Program (CCOP) Affiliates; oversight of all research conducted at Christiana Care by external entities such as partners in the Delaware Health Sciences Alliances (e.g. the University of Delaware); design and implement internal and external processes, methods, approaches and systems which improve productivity, effectiveness and service.

PRINCIPAL DUTIES AND RESPONSIBILITIES

• All aspects of the IRB protocol submission process and renewal process as well as post-approval oversight.
• Full responsibility for all federal, state, local, pharmaceutical, device and other regulatory/oversight clinical trial audits.
• In consultation with the IRB Chairperson(s), manage and coordinate a review of all policies and procedures, user and operations manuals, and office workflow.
• Oversee the development and integration of the IRB into a web-based, system-wide process interfacing with the Research and Grants Administrative Program.
• Review new human subject regulations or changes in regulation (federal, state, local) assure compliance with guidelines, and coordinate the dissemination of information and recommendations to the IRB(s), other research administrative offices, clinical researchers.
• Ensure that all clinical researchers meet an exemplary standard of knowledge with respect to human subject regulations and the scientific and ethical framework of clinical research utilizing human subjects.
• In consultation with the VP/Physician Leader and the IRB Chair(s), develop a program to recruit additional expertise and members to the IRB and provide beginning and continuing human subject protection education for IRB members.
• Represent Christiana Care as a member of the State of Delaware Interdisciplinary Ethics Committee (DEEP)
• On Call 24/7 365 days for Emergency IND/IDE requests
• Respond to research participant concerns with respect to Research Participant Rights in biomedical/behavioral research
• Provide monthly education to the internal and external research community via monthly Current Issues in Research Grand Rounds, symposium presentations, workshops, other lectures and educational endeavors.
• Participate in the Research Leadership Team meetings (chaired by the VP/Physician Leader) and present on topics relevant to IRB as requested.
• Responsible for educating Medical Staff Resident, Nursing, Allied Health Care Professionals, students and others with respect to Human Research Participant Protection, Responsible Conduct of Research and Research Ethics.
• Serve as the liaison to the Nursing Research Committee

EDUCATION AND EXPERIENCE REQUIREMENTS:

• MD, Ph.D., Master's with additional qualifications, or equivalent degree in a health-related or administrative discipline. Post-doctoral experience highly desirable
• At least five years experience in a regulatory or research leadership environment. Previous experience in management of research or related academic, biomedical or behavioral science fields required.
• Five (5) years experience as a member of a biomedical and behavioral Institutional Review Board
• Certification as an IRB Professional (CIP). Active visibility and participation on national level professional organizations
• Experience with management of a multiple IRB system is required.
• Experience in working with external IRBs is required.
• An equivalent combination of education and experience may be substituted.

Supporting informational websites: https://research.christianacare.org/

https://christianacare.org/forhealthprofessionals/research/irb/