Research Coordinator, IRB ( Institutional Review Board )
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• Attend IRB meetings to assist with the electronic review of protocols and document IRB meetings according to IRB policies and procedures and federal regulations to ensure appropriate documentation for any and all audits including those of federal government agencies responsible for the oversight of humans subjects protection in research such as the Office of Human Research Protection and the Food and Drug Administration. Perform other duties as requested.
- Minimum two (2) years of experience in human subjects protection area of research, which includes working with both professional and lay people.
- Minimum two (2) years of experience in a position requiring managing multiple priorities and activities.
- Bachelor's degree in a health-related field OR four (4) years of experience in a directly related field.
- High School Diploma or General Education Development (GED) required.
License, Certification, Registration
- Working knowledge of the regulations of the FDA and DHHS pertaining to human subjects research.
- Comprehensive knowledge of medical and health care issues sufficient to communicate effectively to researchers, staff, IRB members and other customers.
- Ability to interpret and apply ethical principles related to the participation of human subjects in research.
- Excellent interpersonal skills to work effectively and diplomatically with researchers, staff, IRB members and other customers.
- Excellent written communication skills to write professional minutes and letters.
- Excellent time management skills in performing against deadlines with frequent interruptions and competing priorities.
- Ability to follow through with assignments and independently prioritize work.
- Demonstrated ability to work well both independently and in a team-oriented environment.
- Ability to organize effective record keeping and information retrieval systems.
- Excellent attention to detail.
- Ability to maintain confidentiality of information and records with tact and discretion.
- Advanced skills with Microsoft Office software (Word, Excel, PowerPoint).
- Minimum three (3) years of experience in human research subjects protections, including work with both professional and lay people.
- Minimum three (3) years of experience in a position requiring managing multiple priorities and activities.
- Experience working with an electronic IRB system.
- Master's degree with specialized courses in social sciences, business, management, or health-related field.
- Certification as a Certified IRB Professional.
- Thorough knowledge of regulations of the FDA, DHHS, and State of Oregon laws pertaining to human subjects research and the HIPAA Privacy rule.
- Thorough knowledge of KP policies and procedures for doing research with human subjects.
- Thorough knowledge of philosophy and function of an IRB.
External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with federal and state laws, as well as applicable local ordinances, including but not limited to the San Francisco and Los Angeles Fair Chance Ordinances.