Providence Health & Services Institutional Review Board Coordinator in Seattle, Washington
Providence is calling an Institutional Review Board Coordinator to Providence Health & Services in Seattle, WA.
We are seeking an Institutional Review Board Coordinator to serve as a primary regulatory resource and liaison for investigators and Providence researchers to ensure compliance with regulatory and institutional requirements. The position will provide administrative support by processing project submissions, expedited reviews, full board reviews, amendments, adverse events, protocol modification, informed consent documents (ICDs), or other related documentation.
This is an intermediate level position and will be responsible for effective communication and collaboration with peers, colleagues and external customers, including IRB members (Government representatives), researchers, coordinators, assistants and others to effectively contribute to the achievement of the organization’s goals, objectives and desired outcomes.
In this position you will:
Serve as a knowledgeable specialist and consultant to all levels of staff within Providence involved in conducting research for the health system.
Be responsible to establish and maintain a comprehensive resource library including department forms, tools, web content, etc. regarding all aspects of IRB issues, research protocols, and consent form information.
Provide consultation in the development and revision of policies/procedures as well as consent forms to assure consistency with legal, Institutional Review Board, and DHHS requirements.
Prepare for and attend monthly Institutional Review Board meetings; may assist with agendas and meeting minutes.
Coordinate review of compassionate use studies with the requesting physician/office, drug companies, and IRB chairperson.
Coordinate review of expedited study requests (for non-invasive studies or others previously approved before by other local IRB committees) with the requesting MD/office, drug companies, and IRB chairperson.
Collaborate with MDs/office staff for all studies regarding scheduling for IRB meetings and consent revision.
Assign primary and secondary reviewers to studies for IRB meetings as per practice specialty and committee member availability.
Review and confirm the changes/revisions done by others for final approval process.
Collaborate with other IRB personal to clarify questions/concerns and provide required study documentation.
Participate in and provides IRB information for regulatory research base audits.
Participate in ongoing IRB education opportunities.
Process protocol modifications, adverse event reports, and study violations per OHRP and PH&S policy.
Must be able to travel between Providence facilities as necessary.
Required qualifications for this position include:
Bachelor’s Degree or equivalent education or experience in health related field, or education or psychology field.
Minimum of two years’ experience specifically in clinical research, research administration, regulatory compliance or IRB.
Computer proficiency including MS Word, PowerPoint, and experience developing and maintaining web site content.
Be well-versed in applicable regulations, including human research subject’s protections.
Preferred qualifications for this position include:
- CIM, CIP or SOCRA certification.
About the department 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 a full comprehensive range of benefits - see our website for details
As people of Providence, we reveal God's love for all, especially the poor and vulnerable, through our compassionate service.
Providence Health & Services is the third largest not-for-profit health system in the United States. Providence employs more than 76,000 caregivers (employees) across a five-state area; AK, WA, MT, OR, and CA. Our facilities include 34 hospitals, 475 physician clinics, senior services, supportive housing and other health and educational services. 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: Administrative Support (Clinical)
Req ID: 138581