Health care is constantly changing, and at Banner Health, we are at the front of that change. We are leading health care to make the experience the best it can be. We want to change the lives of those in our care ??? and the people who choose to take on this challenge. If changing health care for the better sounds like something you want to be part of, we want to hear from you.
Banner Health is seeking a dynamic leader to provide overall strategic leadership as well as development and management of system-wide compliance for the Human Research Protection Program (HRPP) and the management of team members who provide support to Banner Institutional Review Board and regulatory affairs.?? Fully accredited by AAHRPP, Banner Health has established a comprehensive HRPP to promote the welfare and rights of human research participants, to facilitate excellence in human research, and to provide timely and high-quality IRB review, education, and monitoring of human subjects research.?? As a key leader in Banner Research, the Director will supportively mentor and inspire program team members, serve as the organization's authority on relevant compliance and human research protection issues, and serve as the liaison between Banner Health, our academic partners, and federal regulators.??
In this role, you will have a deep understanding and detailed working knowledge of regulatory requirements for the protection of human subjects research, managerial experience, and proven success in managing an Institutional Review Board or Committee, and will be a highly skilled strategic thinker, and collaborator with key stakeholders.??
This can be a remote position if you live in the following states only: AK, AR, AZ, CA, CO, FL, GA, IA, ID, IN, KS, KY, MI, MN, MO, MS, NC, ND, NE, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI & WY
Your pay and benefits (Total Rewards) are important components of your Journey at Banner Health. Banner Health offers a variety of benefit plans to help you and your family. We provide health and financial security options, so you can focus on being the best at what you do and enjoying your life
Your pay and benefits are important components of your journey at Banner Health. This opportunity includes the option to participate in a variety of health, financial, and security benefits. In addition, this position may be eligible for our Management Incentive Program as part of your Total Rewards package.Banner Alzheimer's Institute (BAI) was established in 2006 as Banner Health's first Center of Excellence. Banner Health is one of the largest nonprofit health care systems in the United States. Our team is uniquely, passionately and strategically committed to ending Alzheimer's without losing another generation and to providing an unparalleled model of care for families facing this devastating disease. BAI is committed to improving people's lives through excellent patient care and advances that capitalize on the best biomedical research. We intend to make a transformational difference in Alzheimer's research and care.
POSITION SUMMARY This position provides leadership in planning, designing, implementing and maintaining an effective Banner system-wide research regulatory compliance program to ensure the protection of human subjects participating in research. Promotes a collaborative and open work environment in a highly matrixed organization. Serves as the primary advisor to the organization???s executive and senior leadership on matters related to compliance with federal and state regulations, guidelines and laws, and local and institutional policies and procedures governing the conduct of research. This position serves as the organization???s liaison with federal, state, and local regulatory agencies, peer institutions and national organizations to enhance organizational compliance. Promotes the culture for the ethical conduct of human subject research at the highest level within the organization. This position is responsible for serving as a role model to staff across the system and representing Banner in a positive manner both within and outside the organization.??
CORE FUNCTIONS 1. Provides oversight and acts as the subject matter expert for the organization regarding the interpretation, implementation and compliance with pertinent federal and state regulations, and organizational policies. Maintains current knowledge of research regulatory compliance requirements; keeping abreast of changes. Interprets and applies federal, state, and local regulations to applicable policies and recommends administrative action. Serves as subject matter expert, providing regulatory and procedural guidance to key stakeholders. Continuously evaluates and adapts policies and procedures, as well as written guidelines, with regards to human subject protection, conflict of interest disclosure and management, occupational health and any other compliance-related functions as may be necessary. Oversees the development and maintenance of a research educational program addressing individual and group needs related to quality expectations and regulatory requirements.
2. Develops research compliance strategies and leads operations that harmonize the interests of Principal Investigators (PIs), human subjects, sponsors, and the organization. Promotes and supports the growth of clinical trial research and grant funded research in a manner consistent with organizational strategic plans. Oversees the research quality management program. Works with the team to develop an annual audit work plan, corrective action plans and resolution of any discovered compliance issues and reports as needed. Shares the annual work plan with executive leadership and the Research Compliance Committee (RCC), which includes an E&C representative. Provides quarterly reports on audit results to executive leadership and the RCC.
3. Oversees and/or directs regulatory oversight of human subject and bench research to ensure all studies are conducted in an ethical manner in accordance with established standards of conduct for research and adhere to pertinent federal and state regulations, and organizational policies. Ensures requirements regarding reporting to federal agencies are satisfied (i.e., unanticipated problems involving risks to subjects or others, IRB suspensions/terminations of studies, etc.). Submits, implements, and/or maintains the organization???s Federal-Wide Assurance (FWA), IRB registration, and other applicable committee annual reports.
4. Ensures program accountability for federally mandated research review committees. Serves as primary contact for federal agencies, research participants, investigators, IRBs, executive leadership, etc. for all matters pertaining to human subject protection. Serves as the Human Subject Protection Administrator for the organization.???? Serves as the ex officio member of the Banner Health Institutional Review Board (IRB); advising the committee on key compliance matters pertaining to human subject protection, federal and state research regulations and organizational policy. Ensures compliance oversight and accountability when IRB oversight for research projects that have been ceded to an external IRB. Oversees and directs the establishment and maintenance of any required Institutional Biosafety Committees (IBCs) and Data Safety and Monitoring Boards (DSMBs).
5. Serves as the designated Research Integrity Officer (RIO) with primary responsibility for implementing the organization???s research misconduct policy. Submits annual report to the federal Office of Research Integrity (ORI) to maintain the organization???s eligibility to receive Public Health Service (PHS) research funds. Conducts thorough, timely, and confidential investigations of alleged research misconduct. Reports the commencement of an investigation and the final determination to ORI, executive leadership, and the IRB of record.
6. Serves as the organization???s designated research Conflict of Interest (COI) Official. Interprets and applies applicable federal, state, and local regulations. Administers the organization???s research COI policies and ensures compliance with all federal requirements. Oversees the COI database and ensures compliance with annual reporting requirements. Reviews and analyzes individual and institutional significant disclosures to identify real or apparent financial COIs and processes as appropriate. Presides over the Research Conflict of Interest Committee (RCOIC) and manages related committee processes. Prepares reports for RCOIC meetings to facilitate review and development of COI management plans. Conducts or arranges for audits, as appropriate, to assure compliance with COI management controls. Coordinates communications with physicians, staff, RCOIC members and research executive and senior leadership. Updates and maintains COI policies, procedures, forms and database.
7. Leads the process for accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Prepares and submits required accreditation applications and annual maintenance reports. Coordinates AAHRPP site visits as required.
8. Serves as the research liaison to the Banner Ethics & Compliance (E&C) Office and Privacy Office. Reviews highly complex and sensitive questions, concerns and complaints relative to research compliance and research-related privacy matters. Provides leadership and support throughout the organization to ensure reasonable steps are taken to ensure an appropriate and timely response to ethical or legal compliance, HIPAA, or HITECH violations or incidents. Oversees investigations to ensure consistency in the enforcement of corrective actions. Assures any necessary training is provided and completed. Oversees thorough documentation of research compliance and HIPAA related activities to ensure compliance with federally mandated reporting requirements; submits reports as required to regulatory agencies. Participates in regular and ad hoc meetings with both offices; reports issues and corrective actions, as applicable. Assures timely communication of applicable E&C and Privacy office updates to research staff.
Requires a Master???s degree in life sciences, nursing, or health related field and a minimum of seven (7) years of progressive, professional experience in the oversight of bench and/or clinical research. In addition, an equivalent combination of education and experience may be allowed.
Maintenance of current professional certification in research compliance or clinical research (e.g., CHRC, CRA, CIP, CCRA, CCRP, CCRC) required.
Must possess expert knowledge of federal, state and local regulations associated with human subject protection, conflicts of interest, privacy and research compliance regulations is required. Knowledge and experience related to institutional biosafety committees, data safety monitoring boards, and/or other related areas is preferred.
Licensed Registered Nurse. Actual experience conducting research as a PI or research professional.
Additional related education and/or experience preferred.
What might draw you to Banner Health? A great health care career, of course—and a great place to live, no matter what stage of life you’re in. With facilities across the West, there is a health care career for everyone, from big city living in the Phoenix area to friendly small towns in the mountains and plains. As one of the largest nonprofit health systems in the country, Banner Health offers both the stability that comes with success and the possibility of exploring new areas of the country. If you’re looking to be a key contributor to a forward-looking organization, you’ll experience a wide variety of professional advantages:
Our expansive system offers you an unmatched variety of clinical settings – from large urban trauma center to small rural hospital, ambulatory to home health.
Our commitment to healthcare innovation means you always have the latest technologies at your fingertips to help you provide the finest care possible.
The size, success and growth of our system provide you with the stability and options to pursue your desired career path.
Competitive compensation and comprehensive benefits offer you options to complement your unique needs.