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The coordinator facilitates regulatory affairs for clinical research, ensuring compliance with FDA, ICH, and IRB standards. They manage study protocols from startup through closure, including document preparation and regulatory correspondence.
Requirements summary
The role requires a high school diploma or GED, with a bachelor's degree in a health science field or four years of research experience preferred. Candidates should have at least two years of experience in clinical research or regulatory compliance, with professional certification being a plus.
high schoolbachelor degreeprofessional certificateComplianceQuality assuranceClinical researchStandard operating proceduresRegulatory documentationRegulatory affairsInformed consentGood clinical practiceICH guidelinesProtocol managementIRB submissionsFDA guidelinesData coordinationHuman subject protectionInvestigational new drug reporting
Job description
Overview
Looking to be part of something more meaningful?
At HonorHealth, you’ll be part of a team, creating a multi-dimensional care experience for our patients.
You’ll have opportunities to make a difference.
From our Ambassador Movement to our robust training and development programs, you can select where and how you want to make an impact.
HonorHealth offers a diverse benefits portfolio for our full-time and part-time team members designed to help you and your family live your best lives.
Visit honorhealth.com/benefits to learn more.
Join us.
Let’s go beyond expectations and transform healthcare together.
HonorHealth is one of Arizona’s largest nonprofit healthcare systems, serving a population of five million people in the greater Phoenix metropolitan area.
The comprehensive network encompasses six acute-care hospitals, an extensive medical group with primary, specialty and urgent care services, a cancer care network, outpatient surgery centers, clinical research, medical education, a foundation, an accountable care organization, community services and more.
With nearly 17,000 team members, 3,700 affiliated providers and close to 2,000 volunteers dedicated to providing high quality care, HonorHealth strives to go beyond the expectations of a traditional healthcare system to improve the health and well-being of communities across Arizona.
Learn more at HonorHealth.com.
Responsibilities
Job summary
Under the direction of the Program Manager, Regulatory Affairs, this position coordinates, assesses, plans, and facilitates Regulatory Affairs at the Research Institute in the areas of training and compliance, system-wide use of Good Clinical Practice principals, and application of FDA and ICH guidelines. Responsible for the implementation and maintenance of study protocols from planning, through startup, lifecycle and closure. Studies range from industry-sponsored and investigator-initiated investigational agent, tissue acquisition, and chart/imaging review study protocols. Knowledge of clinical research trials regulations i.e., OHRP and the FDA, Good Clinical Practice (GCP) and the International Conference on Harmonisation (ICH) is essential.
ESSENTIAL FUNCTIONS Prepares and submits documents related to the protection of human subjects to the relevant IRB and scientific review groups.
Benefits
Health insurance
Training and development programs
Diverse benefits portfolio
Coordinate and/or review all submissions to the IRB (which may include multiple IRB’s) and other required committees, including new protocol applications, protocol amendments, informed consent documents, progress reports, and serious adverse events (SAE) and Investigational New Drug (IND) Safety Reports.
Review submission of protocols to Institutional Review Boards (internal and external).
This includes exempt, minimal risk and greater than minimal risk human research protocols.
Understand and coordinate with the Program Manager Regulatory Affairs, compliance with regulations as they apply to multi-center clinical research studies.
Develop of regulatory documents, including informed consent templates, and departmental operating procedures.
Be knowledgeable of local, state and federal regulations that apply to human subject’s research, including Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations, sponsor guidelines and all Standard Operating Procedures (SOP).
Interacts with the third party monitors for regulatory compliance and responds to regulatory queries.
Assist research staff and PIs in initiating, following-up, negotiating, and resolving issues regarding current and future submissions; participate in direct discussions with the appropriate regulatory agencies and other parties.
Assist physicians and other staff in meeting human subject protection standards in research.
As necessary, participate in creation of supporting documents for research involving human subjects.
Coordinate and/or review regulatory correspondence with FDA and other regulatory agencies as necessary; interact with FDA and other regulatory agencies on project-related issues, applicable policies and other relevant issues.
Execute and maintain a system for maintenance of all regulatory documents, including study-specific regulatory binders.
Execute and maintain online database for tracking all study documents.
Review sponsor guidelines for each study to ensure compliance with Standard Operating Procedures; suggest modifications as necessary for compatibility.
EDUCATION High School Diploma or GED Required Bachelors in health science field, or 4 years related research experience. Preferred
EXPERIENCE 5 years Regulatory Affairs experience Preferred 2 years experience in clinical research, or data coordination; document and regulatory management; regulatory compliance; and quality assurance or combination of relevant experience Preferred
LICENSE AND CERTIFICATIONS Cert Clin Resch Professio Certification in clinical research by SOCRA (Society of Clinical Research Associates) or ACRP
