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Senior Research Regulatory Affairs Associate

Company: Banner Health
Location: Sun City
Posted on: June 18, 2022

Job Description:

The Regulatory Team is comprised of regulatory associates/specialists who oversee Alzheimer's Disease research, movement disorders research and clinical trials. 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. We are responsible for maintaining the Investigator Site File for all studies electronically. We complete submissions to IRBs and sponsors, update regulatory documents, and respond to compliance questions.As a Senior Research Regulatory Affairs Associate, you will act as an integral person in the Banner Research and as part of study teams helping to facilitate study regulatory processes. You should have a strong sense of urgency and the ability to prioritize your workload. Excels in a busy environment and capable of multitasking while meeting deadlines on time. Are detail orientated and extremely organized. Take ownership of work and provides consistent results.This position is Monday through Friday, 8:00AM - 4:30PM, there is flexibility in start/end times. The primary location for this position will be at the Banner Sun Health Research Institute, on the Banner Boswell campus in Sun City. We spend most of the day on the computer and interacting with staff, monitors/sponsors and IRB.POSITION SUMMARYThis position is expected to demonstrate some degree of personal and professional competency and critical thought processes with guidance. 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 electronic regulatory documents; maintains electronic site documents. Leads coordination of regulatory activities with sponsors, clinical research organizations (CROs), clinical research staff, institutional review boards (IRBs) and other internal stakeholders.CORE FUNCTIONS1. Prepare and submit research applications and perform regulatory study start up activities, edit informed consents and other related documents, may assist Principal Investigators (PIs) with protocol and study-related document development, facilitate completion of ongoing continuation reports to the IRB which include adverse event and protocol deviation reporting, study amendment reporting and complete other submissions to respective IRBs as required.2.Maintain all electronic regulatory documents including protocols, investigator brochures, consents, and recruiting materials. facilitate completion of continuing reviews and amendments 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 staff regarding IRB submissions and approvals of study-related documents. Maintain protocol status updates for pending and active projects. May 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, sponsor monitoring, audits and the FDA inspections for review of electronic regulatory binders. Serve as the liaison and expert regulatory representative and professional resource for assigned projects. Interact with sponsors, participating research institutions, CROs, regulatory agencies, and involved institutional departments on behalf of the PI or the IRB.5.Coordinate regulatory activities with the needs of research staff or the IRB to ensure timely submission of all regulatory documents and requests of sponsors.6. Maintain up-to-date knowledge on federal, state, and local research regulatory requirements. 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.7. Perform other administrative duties as required to support the senior regulatory staff or the site's RD or CTSM.MINIMUM QUALIFICATIONSRequires a bachelor's degree in business, healthcare administration or science related field or at least two to three 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 -), or Certified Clinical Research Coordinator (CCRC -) or equivalent additional years of direct research regulatory experience.Must possess 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 fast paced 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 CTMS (Complion, iRIS).PREFERRED QUALIFICATIONSAdditional related education and/or experience preferred.

Keywords: Banner Health, Sun City , Senior Research Regulatory Affairs Associate, Other , Sun City, Arizona

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