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Research Coordinator, IRB ( Institutional Review Board )

Location Portland, Oregon Job Number 982812 Date posted 08/03/2021
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The purpose of this position is to perform preliminary review of research study submissions to the Kaiser Permanente Northwest Institutional Review Board (KPNW IRB) for consistency, completeness, and compliance with federal and state regulations and KPNW IRB policies and procedures. Maintains appropriate documentation of these studies to ensure compliance with research regulations and policies and procedures. Prepares IRB meeting agenda, attends IRB meetings, records and writes IRB meeting minutes, and follow-up correspondence.


Essential Functions:

• Facilitates efficient and timely IRB review of new research proposals and other electronic IRB submissions by performing preliminary review to ensure consistency, completeness, and compliance with federal, state and local laws and KPNW IRB standard operating procedures pertaining to research with human subjects. Provides expert advice and knowledge on regulatory requirements and KPNW policies and procedures to investigators and study staff regarding their IRB submissions. Determines appropriate level of review and forwards submission for expedited review or full board review. Prepares agenda for IRB meetings including assigning Board members to studies taking into consideration their areas of knowledge and expertise.

• 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.

Basic Qualifications:
- 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
- N/A
Additional Requirements:
- 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).


Preferred Qualifications:
- 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.

Primary Location: Oregon,Portland,Center for Health Research Scheduled Weekly Hours: 40 Shift: Day Workdays: Mon - Fri Working Hours Start: 08:00 AM Working Hours End: 04:00 PM Job Schedule: Full-time Job Type: Standard Employee Status: Regular Employee Group/Union Affiliation: NUE-NW-01|NUE|Non Union Employee Job Level: Entry Level Department: Center for Health Research Travel: No Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status.

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.