With supervision, this position 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 sites 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.
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.
Assists in developing and maintaining all the sites 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.
May function as the sites 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.
May function as the sites 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.
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.
May be designated as the regulatory point-person for audits performed by regulatory agencies (i.e. OHRP, ORI, and FDA).
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.
Perform other administrative duties as required to support the Regulatory Affairs Coordinator (RAC), RAC Manager, RAC Senior Manager, or the sites 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
Experience as typically acquired through 1-2 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.
Internal Number: 258678
About Banner Health
You want to change the health care industry – one life at a time. You belong here. You’re excited to be part of the dramatic changes happening in the health care field. In fact, you thrive on change. But you also understand that excellent, compassionate patient care is the true measure of the success of these changes. You belong at Banner Health. Our award-winning, comprehensive health system includes 23 hospitals in seven western states, primary care health centers, research centers, labs, a network of physician practices and much more. Throughout our system, skilled, compassionate professionals use the latest technology to change the way care is provided. If you’re looking to be a key contributor to a forward-looking organization, you’ll experience a wide variety of professional advantages: •Our vision for changing the future of health care gives you the opportunity to leverage your abilities to achieve something historic. •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 system also includes hospitals specializing in cancer, heart health and pediatrics. •Our many loc...ations also translate into a broad selection of exciting and rewarding lifestyle options – from the big city to the wide-open spaces. •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. •Our competitive compensation and comprehensive benefits offer you options to complement your unique needs.