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This position serves as lead for IRB compliance assurance. Responsibilities include monitoring and auditing all research projects within the program to ensure compliance with all state and federal laws and University policies related to human subjects. Identify compliance issues, recommend corrective action, and report to proper authority. Consult with Principal Investigators and other faculty and staff to bring their research into conformance with review protocols and standards.
Manage the informed consent program to ensure that all study participants are notified of study specific details prior to their agreement to participate. Ensure participants are fully informed regarding what data is being collected and maintained, and they are aware of data security measures in place to protect data.
This position will ensure that all projects and studies involving human subjects are reviewed, approved, and that all documents required by federal, state, and University laws, regulations, and policies are attained.
A Bachelor’s degree in a field relevant to area of specialization and three (3) years of experience directly related to the specialty area. Any combination of relevant education and experience may be substituted for the educational requirement on a year-for-year basis.
Master’s degree in a relevant field of study.
Experience participating in or coordinating Institutional Review Boards.
Experience working at a research university which has included experience with federal regulatory compliance requirements.
Compliance Officer – 45%
Reviews project protocols and participates in developing alternate procedure(s).
Monitors and audits projects to ensure compliance with state and federal laws and University policies. Conducts study site visits as needed, travelling as necessary.
Identifies and communicates compliance issues to project staff and faculty. Provides assistance to Principal Investigators concerning compliance issues. Guides PI’s through the process of bringing their projects into conformance with minimum review standards.
Reports problems as needed to applicable governing bodies and/or review boards.
Maintains documentation of project approvals, as outlined by University policies.
Assists staff and faculty with development of solutions to resolve compliance issues. Follows-up to ensure that staff and faculty have addressed issues and implemented approved solutions.
Ensures that all study participants have received information regarding the study, data that will be collected, how the data is stored, and the security measures that are in place to ensure their data is protected. Manages the informed consent portion of all the research studies ensuring that all forms are on file before the participant begins the study.
Reviews documents at study completion. Ensures that all documents are available and meets compliance requirements.
Reviews and addresses any complaints from study participants and/or investigators. Resolves issues and escalate issues to supervisor if necessary.
IRB Coordination – 25%
Prepares IRB and other review board submissions, including initial applications, amendments, renewals, and closures. Ensures that all projects utilizing human subjects are fully documented as required by federal, state, and university laws, regulations, and policies. Reviews and approves IRB documents.
Trains staff in IRB, and other related, research policies and best practices. Provides training and information concerning technical and ethical requirements when human subjects research is being conducted. Ensures that all faculty and staff are trained regarding human subjects law and regulation.
Assists project staff with the management and direction of project field staff.
Prepares and submits quarterly and annual reports on the activities of IRB projects.
Project Start-up – 25%
Works with start-up team to develop project approval plans. Completes a technical review of proposed projects. Ensures viability of the project and that it meets the ethical standards that are in place.
Participate in project protocol development. Provide compliance guidance during the protocol development stage.
Participate in Operations Manual development and Board Member Manual development to ensure compliance with state and federal laws and University policies.
Other – 5%
Other duties as assigned.
WASHINGTON STATE UNIVERSITY IS AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EDUCATOR AND EMPLOYER. Members of ethnic minorities, women, special disabled veterans, veterans of the Vietnam-era, recently separated veterans, and other protected veterans, persons of disability and/or persons age 40 and over are encouraged to apply.
WSU is committed to excellence through diversity and faculty-friendly policy action, including partner accommodation and NSF ADVANCE Institutional Transformation programs (http://www.advance.wsu.edu/).
WSU employs only U.S. citizens and lawfully authorized non-U.S. citizens. All new employees must show employment eligibility verification as required by the U.S. Citizenship and Immigration Services.
WSU is committed to providing access and reasonable accommodation in its services, programs, activities, education and employment for individuals with disabilities. To request disability accommodation in the application process, contact Human Resource Services: 509-335-4521(v), Washington State TDD Relay Service: Voice Callers: 1-800-833-6384; TDD Callers: 1-800-833-6388, 509-335-1259(f), or email@example.com.
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