Note: The job is a remote job and is open to candidates in USA. Phoenix Children's is a pediatric health system focused on exceptional care, innovative research, and medical education. The IRB Program Manager supervises the development, implementation, and evaluation of clinical research trials, ensures compliance with IRB and regulatory requirements, and provides guidance to investigators, coordinators, IRB members, and institutional officials.
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 (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
Skills
- • Bachelors degree in a related field
- • Four (4) or more years of experience in human research protection administration
- • Certification in IRB Management (CIM) or Certified IRB Professional (CIP) OR qualified to sit for exam and pass exam prior to employment start date
- • Cert in IRB Management OR Cert IRB Professional - Required
- • Physical Requirement - Feeling (sensing textures and temperatures) - Occasionally
- • Physical Requirement - Fine Motor Skills (pinching, gripping, etc) - Occasionally
- • Physical Requirement - Hearing - Frequently
- • Physical Requirement - Pushing/pulling - Occasionally
- • Physical Requirement - Reaching - Occasionally
- • Physical Requirement - Sitting - Frequently
- • Physical Requirement - Standing - Frequently
- • Physical Requirement - Stooping/crouching/kneeling/crawling - Occasionally
- • Physical Requirement - Talking - Frequently
- • Physical Requirement - Walking - Occasionally
- • Physical Requirement - Near Vision - Frequently
- • Physical Requirement - Far Vision - Occasionally
- • Physical Requirement - Color Discrimination - Occasionally
- • Physical Requirement - Use of keyboard, mouse and/or computer equipment - Frequently
- • Physical Requirement - Lift up to 35 pounds without assistance - Occasionally
- • Occupational Exposure/Risk Potential - Inside office environment - Applicable
- • Occupational Exposure/Risk Potential - Airborne communicable diseases - Applicable
- • Experience with applicable federal and state guidelines and regulations
- • Four (4) or more years of experience as an IRB Coordinator
Benefits
- Telecommuting
- Full-Time employment
- Mon-Fri, Days, 8am-5pm
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