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.
Christiana Care Health System is headquartered in Wilmington, Delaware and is one of the country's largest health care providers, ranking 21st in the nation for hospital admissions. Christiana Care is proudly a Nurse Magnet recognized institution. Christiana Care Health System is also one of the largest health care providers in the mid-Atlantic region, serving all of Delaware and portions of seven counties bordering the state in Pennsylvania, Maryland and New Jersey. A not-for-profit, non-sectarian health system, Christiana Care includes two hospitals with more than 1,100 patient beds, and is a major teaching hospital with two campuses. Christiana Care is continually recognized for excellence on a regional and national level. Our role in the community is expressed in the Christiana Care Way: "We serve our neighbors as respectful, expert, caring partners in their health. We do this by creating innovative, effective, affordable systems of care that our neighbors value."Christiana Care is a great place to work because we value diversity and recognize it to be a core part of our success. Because of the diversity of our employees, affiliated health professionals and volunteers, we are... positioned to meet the unique needs of our patients and community. We acknowledge and celebrate the uniqueness and talent of each employee. Because of our talented workforce we are able to provide a quality healthcare experience to our patients and community. We strive to create an inclusive environment in which individual diversity can be leveraged and thrive. Christiana Care Health System is an equal opportunity employer, firmly committed to prohibiting discrimination, whose staff is reflective of its community and considers qualified applicants for open positions without regard to race, color, sex, religion, national origin, sexual orientation, genetic information, gender identity or expression, age, veteran status, disability, pregnancy, citizenship status, or any other characteristic protected under applicable federal, state, or local law.