Senior Research Regulatory Affairs Associate

Primary City/State:

Phoenix, Arizona

Department Name:

HRPP/Regulatory Affairs-Rsrch

Work Shift:

Day

Job Category:

Research

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As a Senior Research Regulatory Affairs Associate with Banner Alzheimer's Institute in downtown Phoenix, you will play a key role in supporting innovative clinical research focused on advancing the understanding and treatment of Alzheimer's disease and related disorders. In this highly collaborative position, you will serve as a regulatory expert for a variety of research studies, ensuring that protocols, regulatory submissions, and study documentation meet all applicable requirements while helping research teams move projects forward efficiently.

Working closely with investigators, sponsors, research staff, institutional review boards (IRBs), and other stakeholders, you will coordinate and manage regulatory activities throughout the life cycle of clinical research studies. This role is ideal for an experienced research regulatory professional who is comfortable navigating complex regulatory processes, maintaining critical study documentation, and serving as a trusted resource on research compliance and human subject protections. The successful candidate will bring a strong foundation in clinical research regulatory operations and a passion for supporting groundbreaking research that can make a meaningful impact on patients and families affected by Alzheimer's disease.

Schedule: Monday - Friday, 8am-5pm but flexible as long as during regular business hours.

Banner Alzheimer's Institute (BAI) was established in 2006 as Banner Health's first Center of Excellence. Banner Sun Health Research Institute (BSHRI) was founded in 1986. Our team is uniquely, passionately, and strategically committed to ending Alzheimer's disease and other neurodegenerative disorders without losing another generation, advancing oncology research to improve cancer prevention and treatment outcomes, and providing an unparalleled model of care for families facing these devastating diseases. Banner Research is committed to improving people's lives through comprehensive patient care and advances that capitalize on the best biomedical research. We intend to make a transformational difference in Alzheimer's disease, other neurodegenerative disorders, and oncology research and care.

POSITION SUMMARY

This 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 FUNCTIONS
1. 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 QUALIFICATIONS
Requires 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 QUALIFICATIONS
Additional related education and/or experience preferred.

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Banner Health is one of the largest, nonprofit health care systems in the country and the leading nonprofit provider of hospital services in all the communities we serve. Throughout our network of hospitals, primary care health centers, research centers, labs, physician practices and more, our skilled and compassionate professionals use the latest technology to make health care easier, so life can be better. The many locations, career opportunities, and benefits offered at Banner Health help to make the Banner Journey unique and fulfilling for every employee.

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EEO/Disabled/Veterans

Banner Health supports a drug-free work environment.

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