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This role provides opportunities to work with world renowned researchers and work on cutting edge research towards a cure for Alzheimer's disease, and other dementias. The Regulatory Department is a key component of research and we have a major role in the startup and continuing oversight of trials according to the federal regulations. We are the subject matter experts and the go to for our clinical research staff for questions related to regulatory requirements. We work closely as a team and are innovative and willing to share ideas that find better ways to perform regulatory processes. We are using an e-Regulatory system for study binders eliminating most of the paper associated with research. Ideal candidates will have an ACRP or SoCRA Certification or is willing to acquire this certification, as these certifications are highly preferred.
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POSITION SUMMARY This position is expected to demonstrate a high degree of personal and professional competency, critical thought processes, and leadership with minimal guidance. Coordinates the regulatory support to physicians and clinical investigators involved in the conduct or approval of clinical research projects at the investigative site. Provides direction for the daily operational coordination for all regulatory aspects of sponsored, grant-funded and/or investigator-initiated research projects. Serves as the professional resource for regulatory information, handles the submission of regulatory documents; maintains site source documents. Leads coordination of research activities with sponsors, clinical research organizations (CROs) clinical research staff, institutional review boards (IRBs) and other internal stakeholders. CORE FUNCTIONS 1. Prepare and submit research applications and perform regulatory study start up activities, edit informed consents and other related documents, assist Principal Investigators (PIs) with protocol and study-related document development, provide ongoing continuation reports to the IRB which include adverse event reporting, study amendment reporting and coordination of submissions to respective IRBs. 2. Develop and maintain 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. Act as site's regulatory point-person to provide information to the PI, Research Director or Clinical Trial Senior Manager, and study-specific staff regarding IRB submissions and approvals of study-related documents. Maintain protocol status updates for pending and active projects. Participate in departmental meetings, conferences, and educational events. 4. Interact with sponsors and CROs, providing requested regulatory documents throughout the life of a study. Participate in site initiation visits for review of site regulatory binders, and during sponsor site monitoring and audit visits. Serve as the liaison and expert regulatory representative and professional resource for any site-specific projects. Interact with sponsors, participating research institutions, CROs, regulatory agencies, and involved institutional departments on behalf of the PI or the IRB. 5. Coordinate daily operational activities consistent with the needs of research staff or the IRB to ensure timely submission of all regulatory documents and requests of sponsors. Distribute regulatory work load among Regulatory Affairs Coordinators I to efficiently accomplish regulatory efforts. 6. Maintain up-to-date knowledge on federal, state, and local research regulatory requirements. Train research staff in regulatory matters. Demonstrate support of regulatory compliance through the creation of training documents and standard operating procedures (SOPS). Provide training of research staff to assure compliance with study protocols; federal, state, sponsor, and local rules, regulations, statutes and policies. 7. Serve as designated regulatory point-person for audits performed by regulatory agencies (i.e., OHRP, ORI, and FDA). 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) Manager, RAC Senior Manager, or the site's RD or CTSM. Performs 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 provides 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 coordinate the regulatory requirements for daily operations MINIMUM QUALIFICATIONS Requires a Bachelor's degree in business, healthcare administration or science related field or at least five (5) years of substantial and ongoing professional experience working in the research regulatory environment. In addition, an equivalent combination of education and experience may be allowed. Must have Professional designations such as Certified Clinical Research Professional (CCRP(r)), or Certified Clinical Research Coordinator (CCRC(r)). A qualified candidate may be hired without current certification, but will be required to obtain such certification within the first 2 years of employment. Must possess significant knowledge and understanding of the applicable regulatory requirements, as well as the commonly accepted concepts, practices and procedures within the research regulatory arena. In addition, must be able to use them in varied situations. Ability to plan, organize, set priorities, and work in a fastpaced environment and handle multiple projects. Demonstrated capacity to problem solve, think critically and creatively, and provide assistance through a consultative role. Interpersonal skills necessary to establish and maintain effective working relationships. Computer proficiency including, but not limited to: operational knowledge of Microsoft Office computer applications (such as MS Word, Outlook, Excel), ability to locate and synthesize information on the internet, experience working with electronic databases (such as iRIS, IRBNet, Click(r)). PREFERRED QUALIFICATIONS Additional related education and/or experience preferred.