Senior Research Regulatory Affairs Associate

Banner Health • Phoenix, AZ

20h • Onsite

About The Position

As a Senior Research Regulatory Affairs Associate with Banner Alzheimer's Institute in downtown Phoenix, Arizona, this role supports clinical research focused on Alzheimer's disease and related disorders. The associate serves as a regulatory resource for a variety of research studies, ensuring protocols, submissions, and study documentation meet applicable requirements and helping research teams move projects forward efficiently.

The position provides direction for daily operational coordination of regulatory aspects of sponsored, grant-funded, and investigator-initiated research projects. It handles electronic regulatory submissions and maintains electronic site documents, while coordinating regulatory activities with investigators, sponsors, clinical research organizations, research staff, institutional review boards, and other stakeholders throughout the life cycle of studies.

The schedule is Monday through Friday, 8 a.m. to 5 p.m., with flexibility as long as work occurs during regular business hours. The role is based at Banner Alzheimer's Institute in downtown Phoenix.

Requirements

• Bachelor's degree in business, healthcare administration, or a science-related field, or at least two to three years of substantial and ongoing professional experience in the research regulatory environment; an equivalent combination of education and experience may be allowed.
• Professional designation such as Certified Clinical Research Professional (CCRP®), Certified Clinical Research Coordinator (CCRC®), or equivalent additional years of direct research regulatory experience.
• Knowledge and understanding of applicable regulatory requirements and commonly accepted concepts, practices, and procedures in research regulation, with the ability to apply them in varied situations.
• Ability to plan, organize, set priorities, work in a fast-paced environment, and handle multiple projects.
• Demonstrated ability to problem solve, think critically and creatively, and provide assistance in a consultative role.
• Interpersonal skills to establish and maintain effective working relationships.
• Computer proficiency, including operational knowledge of Microsoft Office applications such as Word, Outlook, and Excel; ability to locate and synthesize information on the internet; and experience working with CTMS systems such as Complion and iRIS.

Nice To Haves

• Additional related education and/or experience.

Responsibilities

• Prepare and submit research applications and perform regulatory study start-up activities.
• Edit informed consents and related documents, and potentially assist Principal Investigators with protocol and study-document development.
• Facilitate ongoing IRB continuation reports, including adverse-event and protocol-deviation reporting, study-amendment reporting, and other required IRB submissions.
• Maintain electronic regulatory documents, including protocols, investigator brochures, consent forms, and recruiting materials.
• Facilitate continuing reviews and amendments in accordance with sponsor and participating-institution requirements, Good Clinical Practice, FDA and other applicable regulations, policies, procedures, and guidelines.
• Serve as the site regulatory point person, providing information to the PI, Research Director or Clinical Trial Senior Manager, and study staff regarding IRB submissions and approvals.
• Maintain protocol status updates for pending and active projects; may participate in departmental meetings, conferences, and educational events.
• Provide requested regulatory documents to sponsors and CROs throughout studies, and participate in site initiation visits, sponsor monitoring, audits, and FDA inspections involving electronic regulatory binders.
• Serve as the regulatory liaison and expert representative for assigned projects, interacting with sponsors, participating research institutions, CROs, regulatory agencies, and institutional departments on behalf of the PI or IRB.
• Coordinate regulatory activities with research staff and the IRB to ensure timely submissions of regulatory documents and sponsor requests.
• Maintain current knowledge of federal, state, and local research regulatory requirements and serve as the designated regulatory point person for audits performed by agencies such as OHRP, ORI, and FDA.
• Engage in customer-service core measures and uphold professional standards for human-subject protection in clinical research.
• Perform other administrative duties as required to support senior regulatory staff or the site's Research Director or Clinical Trial Senior Manager.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior