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Banner Alzheimer's Institute is looking for a Research Regulatory Affairs Associate. Do you have passion for clinical research? If you have a strong sense of urgency, the ability to prioritize workloads, and meet deadlines, we are looking for you! The Regulatory Affairs position works closely with coordinators, clinicians, and clinical trial staff in an inclusive environment with the goal of making lasting contributions to dementia and movement disorder research.
Your pay and benefits are important components of your journey at Banner Health. Banner Health offers a variety of benefits 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.
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, with supervision, provides regulatory support to physicians and clinical investigators involved in the conduct of clinical research projects at the investigative site. Provides daily operational coordination for all regulatory aspects of sponsored, grant-funded and/or investigator-initiated research projects. Handles the submission of regulatory documents and maintains investigative site's regulatory source documents. Ensures coordination of research activities with sponsors, clinical research organizations (CROs), clinical research staff, institutional review boards (IRBs) and other internal stakeholders.
CORE FUNCTIONS 1. Assists in preparing and submitting research applications and performing regulatory study start up activities, editing informed consents and other related documents, providing ongoing continuation reports to the IRB which include adverse event reporting, study amendment reporting and coordination of submissions to respective IRBs.
2. Assists in developing and maintaining all the site's study and regulatory documents including study amendments, recruiting material, continual reviews and safety reports per sponsor, participating institutions, Good Clinical Practice (GCP), FDA and other applicable federal, state and local regulatory agency regulations, policies and procedures, and/or guidelines.
3. May function as the site's point-person who provides information to the Principal Investigator (PI), Research Director (RD) or Clinical Trial Senior Manager (CTSM), and study-specific staff regarding IRB submissions and approvals of study-related documents. Maintain protocol status updates for pending and active projects.
4. May function as the site's point-person for the sponsors and CROs, providing requested regulatory documents throughout the life of the study. May participate in site initiation visits for review of site regulatory binders, and during sponsor site monitoring and auditing visits.
5. May serve as the regulatory representative or resource for any site-specific projects. May interact with sponsors, participating research institutions, CROs, regulatory agencies, and involved institutional departments on behalf of the PI or the IRB.
6. May be designated as the regulatory point-person for audits performed by regulatory agencies (i.e. OHRP, ORI, and FDA).
7. Supports the coordination of daily operational activities with the needs of research staff or the IRB to ensure timely submission of all regulatory documents and requests of sponsors. Engage in core measures of customer service. Exhibit professional standards to ensure human subjects protection in the conduct of clinical research.
8. Perform other administrative duties as required to support the Regulatory Affairs Coordinator (RAC), RAC Manager, RAC Senior Manager, or the site's RD or CTSM. Perform all functions according to established policies, procedures, regulatory and accreditation requirements, as well as applicable professional standards. Provides all customers of Banner Health with an excellent service experience by consistently demonstrating our core and leader behaviors each and every day
9. This position assists in providing regulatory oversight, organization and coordination of research involving all physicians and clinicians and involved departments within the assigned site. The primary site will be identified and the candidate will assist in coordinating the regulatory requirements for daily operations.
Experience as typically acquired through one to two years of research trial coordination. Working knowledge of federal regulations and a significant understanding and knowledge of commonly used concepts, practices and procedures within the regulatory arena. Proven analytical skills required. Must be able to prioritize multiple projects. Excellent human relations, organizational and communication skills are required.
Working knowledge of Microsoft computer applications is required.
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.