Coordinator Regulatory Affairs II

4 days ago

Phoenix, United States HonorHealth Full time

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 nine 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 16,000 team members, 3,700 affiliated providers and close to 1,100 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 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. Prepares and submits documents related to the protection of human subjects to the relevant IRB and scientific review groups for new protocol applications, protocol amendments, deviations/violations, continuing reviews, serious adverse event (SAE) reporting Investigational New Drug (IND) Safety Reports. This includes exempt, minimal risk and greater than minimal risk human research protocols. Prepares and submits documents related to the protection of human subjects to the relevant IRB and scientific review groups for new protocol applications, protocol amendments, deviations/violations, continuing reviews, serious adverse event (SAE) reporting Investigational New Drug (IND) Safety Reports. This includes exempt, minimal risk and greater than minimal risk human research protocols. Understand and coordinate with the Supervisor Regulatory Affairs, compliance with regulations as they apply to multi-center clinical research studies. 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). 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. Interacts with the third party monitors for regulatory compliance and responds to regulatory queries. 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. Qualifications Education Bachelor's Degree or 4 years' work related experience Required Experience 2 years experience in clinical research, including data coordination, document and regulatory management, regulatory compliance, and quality assurance. Required

  • Director of Rates and Regulatory Affairs

    2 months ago

    Phoenix, United States Blue Signal Search Full time

    Our client is a prominent global organization in the materials industry, known for its extensive portfolio of valuable assets and significant reserves. With expansive territories in both North and South America, our client is a key player in the industry.The Director of Rates and Regulatory Affairs will lead strategic initiatives related to retail energy...

  • Director of Rates and Regulatory Affairs

    2 months ago

    phoenix, United States Blue Signal Search Full time

    Our client is a prominent global organization in the materials industry, known for its extensive portfolio of valuable assets and significant reserves. With expansive territories in both North and South America, our client is a key player in the industry.The Director of Rates and Regulatory Affairs will lead strategic initiatives related to retail energy...

  • Director of Rates and Regulatory Affairs

    6 months ago

    Phoenix, United States Blue Signal Search Full time

    Our client is a prominent global organization in the materials industry, known for its extensive portfolio of valuable assets and significant reserves. With expansive territories in both North and South America, our client is a key player in the industry.The Director of Rates and Regulatory Affairs will lead strategic initiatives related to retail energy...

  • Coordinator II

    4 weeks ago

    Phoenix, United States Phoenix Children's Hospital Full time

    Position Details Department: PCHF | Foundation Location: Phoenix Shift: Mon-Fri, Days, 8am-5pm Category: Foundation Posting #: 887461 Employee Type: Full-Time Position Summary The Coordinator II's primary responsibility is to assist with managing relationships, partnerships, programs, events and campaigns that result in growing annual revenue for the...

  • Clinical Research Coordinator II

    1 month ago

    Phoenix, United States Cedent Consulting Inc Full time

    Summary:The Clinical Research Coordinator II is responsible for managing and overseeing clinical trials working closely with a team under the direction of the Site Operations Manager. This role ensures smooth trial operations participant monitoring and data collection while maintaining compliance with protocols and regulatory standards.Key...

  • Warehouse Coordinator II

    6 months ago

    Phoenix, United States Lincare Holdings Inc. Full time

    The Warehouse Coordinator II is responsible for maintaining various warehousing functions that include shipping and receiving, cleaning equipment, purchasing, and inventory. Maintains an organized, clean, and safe warehouseCompletes monthly inspection of all time-sensitive goods to ensure no expired products are on shelvesMaintains adequate "on time"...

  • Benefits Coordination Specialist II

    1 week ago

    Phoenix, Arizona, United States USI Insurance Services, Inc. Full time

    Job SummaryWe are seeking a highly skilled Benefits Administrator II to join our team at USI Insurance Services, Inc. In this role, you will be responsible for the coordination of day-to-day customer service and supporting internal service teams.About the RoleThis position requires a strong ability to ensure new business, renewals, and broker of record...

  • Data Integrity Specialist II

    2 weeks ago

    Phoenix, Arizona, United States Central Admixture Pharmacy Services, Inc. Full time

    About Central Admixture Pharmacy Services, Inc.Central Admixture Pharmacy Services, Inc. is a leading provider of innovative medical products and services to the healthcare industry. We develop, manufacture, and market a wide range of solutions to improve patient care and outcomes.Job SummaryWe are seeking an experienced Data Integrity Specialist II to join...

  • Clinician II

    3 weeks ago

    Phoenix, United States Terros Full time

    Job Details Job Location Desert Cove - Phoenix, AZ Position Type Full Time Education Level High School Diploma/GED   Travel Percentage In-Office Job Shift Day Shift Job Category Behavioral Health/Social Work Description Responsibilities: As a Clinician II you will be responsible for screenings, assessments, treatment planning, case load management,...

  • Care Coordinator II School Based

    1 day ago

    Phoenix, United States Valle Del So Full time

    About Valle del SolJoin Valle del Sol in our commitment to providing quality, culturally sensitive integrated primary care and behavioral health services to adults, children, and adolescents in need. Valle del Sol offers a diverse work environment, competitive pay and benefits, and the opportunity for training and advancement.Job Description:This individual...

  • Clinician II

    1 week ago

    Phoenix, United States Terros Full time

    Job Details Job Location Desert Cove - Phoenix, AZ Position Type Full Time Education Level High School Diploma/GED   Travel Percentage In-Office Job Shift Day Shift Job Category Behavioral Health/Social Work Description Now Offering a $3,000 Sign-on/Retention Bonus!!! Responsibilities: As a Clinician II you will be responsible for screenings, assessments,...

  • Clinician II

    2 weeks ago

    Phoenix, United States Terros Full time

    Job Details Job Location Desert Cove - Phoenix, AZ Position Type Full Time Education Level High School Diploma/GED   Travel Percentage In-Office Job Shift Day Shift Job Category Behavioral Health/Social Work Description Responsibilities: As a Clinician II you will be responsible for screenings, assessments, treatment planning, case load management,...

  • Clinician II

    2 weeks ago

    Phoenix, United States Terros Full time

    Job Details Job Location Desert Cove - Phoenix, AZ Position Type Full Time Education Level High School Diploma/GED   Travel Percentage In-Office Job Shift Day Shift Job Category Behavioral Health/Social Work Description Now Offering a $3,000 Sign-on/Retention Bonus!!! Responsibilities: As a Clinician II you will be responsible for screenings,...

  • Pediatric Dietitian II

    6 days ago

    Phoenix, United States Phoenix Children's Hospital Full time

    Job Description Pediatric Dietitian II Pediatric Dietitian II  Apply!  Apply! Position DetailsDepartment: PCH-MAIN | NutritionLocation: PhoenixShift: Mon-Fri, Days, 8am-5pm Category: Nutrition/DietitianPosting #: 893026Employee Type: Full-Time Position Summary The Pediatric Dietitian II (PD II) is a registered dietitian/nutritionist who is competent in...

  • Pediatric Dietitian II

    2 months ago

    Phoenix, United States Phoenix Children's Hospital Full time

    Job Description Pediatric Dietitian II Pediatric Dietitian II  Apply!  Apply! Position DetailsDepartment: PCMG-MAIN | EndocrinologyLocation: PhoenixShift: Mon-Fri, Days, 8am-5pm Category: Nutrition/DietitianPosting #: 884440Employee Type: Part-Time Position Summary Posting Note: Phoenix Children’s Endocrine division is in search of a Registered...

  • Care Coordinator II School Based

    2 days ago

    Phoenix, United States Valle Del So Full time

    About Valle del Sol Join Valle del Sol in our commitment to providing quality, culturally sensitive integrated primary care and behavioral health services to adults, children, and adolescents in need. Valle del Sol offers a diverse work environment, competitive pay and benefits, and the opportunity for training and advancement. Job Description: This...

  • Customer Navigation Coordinator II

    1 month ago

    Phoenix, United States HonorHealth Full time

    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...

  • Medical Lab Scientist II

    3 weeks ago

    Phoenix, United States Phoenix Children's Hospital Full time

    Job Description Medical Lab Scientist II Medical Lab Scientist II  Apply!  Apply! Position DetailsDepartment: PCH-MAIN | Lab Micro/ComplexLocation: PhoenixShift: Mon-Fri, Sat, Sun, Evenings, 2pm-12:30am Category: Laboratory/PathologyPosting #: 890547Employee Type: Full-Time Position Summary The Medical Laboratory Scientist II performs and interprets...

  • Pediatric Dietitian II

    1 month ago

    Phoenix, United States Phoenix Children's Hospital Full time

    Position SummaryPosting Note: Phoenix Children’s Endocrine division is in search of a Registered dietitian with Diabetes interest and experience. This position is 0.8FTE; it offers one remote day a week, dental, vision, and health insurance. Additionally, it offers tuition reimbursement, paid time off, diabetes technology training, a supportive and...

  • Pediatric Dietitian II

    2 weeks ago

    Phoenix, United States Phoenix Children's Hospital Full time

    Position SummaryPosting Note: Phoenix Children’s Endocrine division is in search of a Registered dietitian with Diabetes interest and experience. This position is 0.8FTE; it offers one remote day a week, dental, vision, and health insurance. Additionally, it offers tuition reimbursement, paid time off, diabetes technology training, a supportive and...