IRB Program Manager

Phoenix Children's Hospital, Inc.; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

Phoenix Children's Hospital, Inc. is seeking a Senior IRB Administrator to supervise the development, implementation, and evaluation of clinical research trials, ensuring compliance with IRB policies and regulations.

The role coordinates resources and offers regulatory guidance to investigators and coordinators involved in human subjects research. The position involves interacting with OHRP and FDA, overseeing IRB operations, and training staff on regulatory requirements.

Qualifications

• Four (4) or more years of experience in human research protection administration.
• Experience with applicable federal and state guidelines and regulations.
• Four (4) or more years of experience as an IRB Coordinator.
• Certification in IRB Management (CIM) or Certified IRB Professional (CIP) OR eligible to sit for exam before employment start date.

Responsibilities

• Coordinates review and approvals of research proposals by investigators through IRB and administrative procedures to ensure compliance with all requirements.
• Interacts with the Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA) and other governmental agencies regarding research regulations; prepares and participates in audits by the OHRP, FDA, or other governmental agencies.
• Oversees day-to-day functions of the IRB, including pre-review of all IRB documents; generates and distributes IRB agendas, meeting packets, minutes, and correspondence in an accurate and timely manner.
• Plans, develops and implements regulatory guideline training programs for physicians, coordinators and IRB members to ensure ongoing familiarity and understanding of applicable laws and requirements.
• Plans, develops, implements, and evaluates all IRB department policies, procedures, and processes; implements quality assurance in conjunction with the Office of Research to ensure compliance with IRB standards and federal/state requirements.
• Provides guidance to research investigators regarding FDA/OHRP requirements/regulations and IRB submission requirements.
• Provides oversight and mentorship to the IRB Coordinator.
• Reviews proposals and determines if they meet criteria for exemption under OHRP and FDA regulations.
• Reviews proposals and determines if they meet the OHRP/FDA definition of Human Subject Research.
• Reviews research study applications to ensure compliance with all federal, state, and regulatory agency requirements and specific institutional requirements; notifies appropriate individual of potentially serious adverse effects, non-compliance, and/or logistically difficult projects.
• Performs miscellaneous job related duties as requested.

Skills

IRB oversight

Regulatory compliance

Leadership

Education

Bachelor's degree in a related field

Job description

Department: RSRCH-GRNT | Clinical Research Admin

Location: Telecommuting

Shift: Mon-Fri, Days, 8am-5pm

Category: Research

Posting #: 1066705

Employee Type: Full-Time

Position Summary

This position supervises the development, implementation, and evaluation of clinical research trials to ensure consistency with all IRB policies and procedures; coordinates resource requirement and utilization to ensure compliance with required federal, state, funding source, and all other applicable governing regulations, requirements, and standards. This position also provides regulatory, ethical and methodological guidance to investigators and coordinators to prepare applications for research proposals involving human subjects and provides consultation to IRB members and institutional officials regarding federal regulations and institutional policy.

Position Duties

• Coordinates review and approvals of research proposals by investigators through IRB and administrative procedures to ensure compliance with all requirements
  
• Interacts with the Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA) and other governmental agencies regarding research regulations; prepares and participates (as necessary) in audits by the OHRP, FDA, or other governmental agencies
  
• Oversees day-to-day functions of the IRB, including pre-review of all IRB documents; generates and distributes IRB agendas, meeting packets, minutes, and correspondence in an accurate and timely manner
  
• Plans, develops and implements regulatory guideline training programs for physicians, coordinators and IRB members to ensure ongoing familiarity and understanding of applicable laws and requirements
  
• Plans, develops, implements, and evaluates all IRB department policies, procedures, and processes; implements quality assurance in conjunction with the Office of Research to ensure compliance with IRB standards and federal/state requirements
  
• Provides guidance to research investigators regarding FDA/OHRP requirements/regulations and IRB submission requirements
  
• Provides oversight and mentorship to the IRB Coordinator
  
• Reviews proposals and determines if they meet criteria for exemption under OHRP and FDA regulations
  
• Reviews proposals and determines if they meet the OHRP/FDA definition of Human Subject Research
  
• Reviews research study applications to ensure compliance with all federal, state, and regulatory agency requirements and specific institutional requirements; notifies appropriate individual of potentially serious adverse effects, non-compliance, and/or logistically difficult projects
  
• Performs miscellaneous job related duties as requested.
  

Phoenix Children's Mission, Vision, & Values

Mission

To advance hope, healing and the best healthcare for children and their families

Vision

Phoenix Children's will be the leading pediatric health system in the Southwest, nationally recognized for exceptional care, innovative research and advanced medical education.

We realize this vision by:

• Offering the most comprehensive care across ages, communities and specialties
• Investing in innovative research, including emerging treatments, tools and technologies
• Advancing education and training to shape the next generation of clinical leaders
• Advocating for the health and well-being of children and families

Values

• We place children and families at the center of all we do
• We deliver exceptional care, every day and in every way
• We collaborate with colleagues, partners and communities to amplify our impact
• We set the standards of pediatric healthcare today, and innovate for the future
• We are accountable for making the highest quality care accessible and affordable

Position Qualifications

Please review the following qualifications and specify whether you meet each of the requirements listed.

Education

Do you meet this requirement or have the ability to obtain it
within the timeframe listed in the requirement? 1. Bachelors degree in a related field
Preferred Yes No

Experience

Do you meet this requirement or have the ability to obtain it
within the timeframe listed in the requirement? 1. Four (4) or more years of experience in human research protection administration
Required Yes No 2. Experience with applicable federal and state guidelines and regulations
Preferred Yes No 3. Four (4) or more years of experience as an IRB Coordinator
Preferred Yes No

Additional Requirements

Do you meet this requirement or have the ability to obtain it
within the timeframe listed in the requirement? 1. Certification in IRB Management (CIM) or Certified IRB Professional (CIP) OR qualified to sit for exam and pass exam prior to employment start date
Required Yes No

Physical Requirements & Occupational Exposure/Risk Potential

1. Physical Requirement - Feeling (sensing textures and temperatures) -Occasionally 2. Physical Requirement - Fine Motor Skills (pinching, gripping, etc) -Occasionally 3. Physical Requirement - Hearing -Frequently 4. Physical Requirement - Pushing/pulling -Occasionally 5. Physical Requirement - Reaching -Occasionally 6. Physical Requirement - Sitting -Frequently 7. Physical Requirement - Standing -Frequently 8. Physical Requirement - Stooping/crouching/kneeling/crawling -Occasionally 9. Physical Requirement - Talking -Frequently 10. Physical Requirement - Walking -Occasionally 11. Physical Requirement - Near Vision -Frequently 12. Physical Requirement - Far Vision -Occasionally 13. Physical Requirement - Color Discrimination -Occasionally 14. Physical Requirement - Use of keyboard, mouse and/or computer equipment -Frequently 15. Physical Requirement - Lift up to 35 pounds without assistance -Occasionally 16. Occupational Exposure/Risk Potential - Inside office environment -Applicable 17. Occupational Exposure/Risk Potential - Airborne communicable diseases -Applicable I have reviewed the qualifications, physical requirementsand occupational exposure/risk potential for this position and wish to apply I Agree