Senior Research Regulatory Affairs Associate

Banner Health

. Support innovative clinical research focused on Alzheimer's disease and related disorders .

Posted 10/27/2026full-timePhoenix • Arizona • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory compliance and clinical research management, with a strong focus on Alzheimer's disease studies. Proficient in coordinating regulatory activities, preparing submissions, and maintaining documentation in accordance with federal and institutional guidelines.

Highest-signal resume keywords

Regulatory ExpertiseClinical Research ManagementCertified Clinical Research Professional (CCRP®)Knowledge of GCP and FDA RegulationsExperience with CTMS

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document PreparationProtocol DevelopmentAdverse Event ReportingStudy Amendment ManagementResearch Application Submission

Soft Skills

Problem SolvingCritical ThinkingInterpersonal SkillsOrganizational SkillsConsultative Assistance

Tools & Technologies

Microsoft WordMicrosoft OutlookMicrosoft ExcelComplionIRIS

Certifications & Qualifications

Certified Clinical Research Coordinator (CCRC®)Certified Clinical Research Professional (CCRP®)

Industry Keywords

Clinical TrialsIRB CoordinationResearch Regulatory EnvironmentFDA InspectionsOHRP Compliance

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Support innovative clinical research focused on Alzheimer's disease and related disorders
Provide regulatory expertise for sponsored, grant-funded, and investigator-initiated research projects
Coordinate and manage regulatory activities throughout the life cycle of clinical research studies
Prepare and submit research applications and perform regulatory study start-up activities
Edit informed consents and related documents and assist Principal Investigators with protocol and study document development
Facilitate IRB continuation reports, adverse event and protocol deviation reporting, study amendments, and other required submissions
Maintain electronic regulatory documents, including protocols, investigator brochures, consents, and recruiting materials
Complete continuing reviews and amendments according to sponsor, participating institution, GCP, FDA, and other applicable requirements
Serve as the site's regulatory point person for investigators, research directors, clinical trial managers, and study staff
Maintain protocol status updates for pending and active projects
Interact with sponsors and CROs and provide requested regulatory documents throughout study life cycles
Participate in site initiation visits, sponsor monitoring, audits, and FDA inspections
Serve as liaison and expert regulatory representative for assigned projects
Coordinate regulatory activities with research staff and IRBs to ensure timely submissions
Maintain up-to-date knowledge of federal, state, and local research regulatory requirements
Serve as designated regulatory point person for audits by OHRP, ORI, FDA, and other regulatory agencies
Support senior regulatory staff, the site Research Director, or Clinical Trial Senior Manager with administrative duties

Requirements

What you’ll need

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
Equivalent combination of education and experience may be allowed
Must have professional designations 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 research regulatory requirements and commonly accepted concepts, practices and procedures
Ability to plan, organize, set priorities, and work in a fast-paced environment while handling 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 Microsoft Word, Outlook, and Excel
Ability to locate and synthesize information on the internet
Experience working with CTMS, including Complion and iRIS

Benefits

Comp & perks

Flexible schedule during regular business hours
Monday-Friday, 8am-5pm schedule
Hybrid work arrangement
EEO/Disabled/Veterans
Drug-free work environment