Providence Health & Services Human Research Protection Program Principal Analyst PSJH in Renton, Washington
Providence St. Joseph Health is calling a Human Research Protection Program Principal Analyst PSJH to our location in Renton, WA.
We are seeking a Human Research Protection Program Principal Analyst PSJH who will serve as a subject matter expert (SME) for research and regulatory staff, as well as other HRPP staff. The HRPP Principal Analyst has in-depth knowledge and understanding of Federal Regulations pertaining to human research and has experience applying regulations to IRB submissions for all types of category determinations (exempt, expedited, convened IRB review, not research, not engaged in research) and for all levels of IRB review (pre-review, re-review, clarifying issues, post meeting, non-committee review) to ensure adherence to regulatory and ethical standards. The HRPP Principal Analyst supports HRPP leadership to manage processes for PSJH research involving human subjects to ensure that it is conducted in a manner that protects the safety, rights, and welfare of research subjects. The HRPP Principal Analyst will support compliance with institutional SOPs and international, federal, state, and local rules and regulations and ethical principles regarding the use of human subjects in research. This is the highest level in the HRPP Analyst job family and serves as a SME with expert-level proficiency in the discipline.
In this position you will:
Serve as a regulatory Subject Matter Expert (SME) for researchers and regulatory staff on IRB regulations, policies, and practices.
Serve as a point of contact for questions, and for decision-making and problem-solving for day-to-day IRB operations including the resolution of technical problems and questions of IRB support staff, IRB members, researchers and investigators. Conducts reviews of biomedical and behavioral research studies in compliance with Federal regulations and Institutional policies and procedures. Under supervision, identifies issues or concerns that must be addressed in order to approve the research in compliance with all regulations.
Conduct reviews of biomedical and social behavioral research proposals submitted to the IRB in compliance with Federal regulations and Institutional policies and procedures. Makes an initial determination regarding the necessary level of review. Identifies issues or concerns that must be addressed in order to approve the research.
Attend Institutional Review Board (IRB) meetings as requested to provide technical support, guidance on regulatory matters and ethics, and provide critical analysis of proposal content. Provides answers to questions raised by the board members.
Compose detailed and complex meeting minutes and correspondence that effectively describe concerns raised by Board reviewers, changes required by the Board to make the study approvable, and the rationale for the Board’s decisions and requested changes.
Review complex proposed research protocols to identify potential problems and make recommendations for their modifications as appropriate, whenever possible.
Assist HRPP team with continuing education for investigators, research teams, and regulatory staff.
Assist with reliance agreements including updating PSJH information in platforms such SmartIRB and IREX.
Assist in the training of and mentoring of HRPP Analysts and other staff.
Assist in the development of IRB education, training, and guidance materials for the research community.
Demonstrate knowledge of department operations and makes recommendations for their improvement.
Provide training and advice to faculty and staff on the regulations and on the preparation of applications and consent forms.
Develop and present training materials on the ethical conduct of research involving human subjects.
Conduct quality and assurance reports for management.
Assist with the analysis and creation of reports that tracks turnaround times and backlogs for management and outside regulatory agency review.
Conceptualize and can formulate the complexity of a project and provide guidance on next steps while integrating the PSJH values and objectives with the overall objective of making the process easier for processing.
Required qualifications this position include:
Bachelor's Degree in Health related field; research
CIP issued by PRIM&R
8 years IRB, regulatory, or research experience; greater than 8 years preferred
Preferred qualifications for this position include:
Master's Degree in relevant academic field or 3 additional years of related experience
4 years working with electronic IRB platform
About the ministry you will serve.
Providence Strategic and Management Services provides a variety of functional and system support services for all eight regions of Providence Health & Services from Alaska to California. We are focused on supporting our Mission by delivering a robust foundation of services and sharing of specialized expertise.
We offer comprehensive, best-in-class benefits to our caregivers. For more information, visit
As expressions of God’s healing love, witnessed through the ministry of Jesus, we are steadfast in serving all, especially those who are poor and vulnerable.
Providence is a comprehensive not-for-profit network of hospitals, care centers, health plans, physicians, clinics, home health care and services continuing a more than 100-year tradition of serving the poor and vulnerable. Providence is proud to be an Equal Opportunity Employer. Providence does not discriminate on the basis of race, color, gender, disability, veteran, military status, religion, age, creed, national origin, sexual identity or expression, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.
Job Category: Research
Req ID: 301443