Position Details: Job Description Summary of Duties:
The Research Compliance Specialist, working with the Assistant Director for the Washington State University (WSU) Human Research Protection Program (HRPP), will develop and implement a program for continuous Quality Assurance (QA) and Quality Improvement (QI) for the WSU HRPP and Institutional Review Board (IRB). This is to ensure University compliance with Federal, State, and local regulations and Institutional policies that govern the use of human subjects in research. WSU human subject research projects come from all departments and academic units, regional campuses, extension offices and/or worldwide. All WSU faculty, staff, and students are welcome to conduct human subjects research. The ability of the University to receive grants and to conduct research with humans depends on the Human Subject Protections Program (HRPP) ensuring compliance with federal and state regulations.
An effective Research Compliance Specialist will help ensure WSU human subjects research is conducted in an ethical and compliant manner. This may require occasional travel to other WSU campuses in order to implement the QA program and to work with external IRB's and regulatory agencies to ensure ethical conduct of research across other states and internationally.
As part of the QI program, the Research Compliance Specialist will provide guidance, including educational presentations and one on one meetings to faculty, staff, students ,and administrators and conduct for cause, and not for cause audits university wide.
Specific duties include but are not limited to:
Independently conduct protocol/project specific for cause audits related to allegations of research non-compliance, adverse event reports and unanticipated problems involving risks to subjects or others (UPIRSO's).
With limited guidance conduct program specific for cause audits of specific areas of concern within IRB or HRPP function that may be non-compliant with regulatory requirements.
Responsible to conduct audits of IRB/HRPP functions as described in the HRPP/IRB Quality Assurance program.
Implement the Post Approval Review/Post Approval Monitoring (PAR/PAM) program by conducting not-for-cause audits of high risk and randomly selected investigator protocols or protocol specific functions (e.g. observation of the informed consent process).
Quality Assurance Program: independently prepare reports and letters of findings; make recommendations for resolving deficiencies/infractions; develop and/or assist with training programs; consult and provide advice in the development and/or maintenance of university human subjects research policies and initiatives.
Assist the HRPP/IRB Office in the review of Exempt/NHSR and Non-exempt research protocols during times of staffing shortage or increased protocol submission volume.
Provide advice or conduct full concurrent reviews for protocols involving high levels of risk or other special considerations (e.g. vulnerable populations, FDA regulations) to ensure that the IRB is conducting effective reviews of high risk protocols.
A Bachelor's degree and two years of experience including planning, policy analysis, coordination and consultation with a variety of public and private agencies, organizations, and/or levels of government OR equivalent education/experience.
Minimum of 2 years' experience in a research compliance, clinical research, clinical research coordinator or clinical research compliance role or research experience in a highly regulated environment (e.g. Human Subject Research).
Demonstrated experience in the use of Microsoft, Adobe, Internet Browser and e-mail systems as well as electronic databases.
Demonstrated understanding of regulatory requirements for the conduct of human subject research (e.g. FDA 21CFR56 and HHS 45CFR46, GDPR) and ethical principles for the conduct of research as outlined in significant publications (e.g. Belmont Report, Declaration of Helsinki).
Ability to obtain certificate as an IRB/Compliance professional within 2 years of employment.
Ability to obtain certification as an IRB/Compliance professional (e.g. CIP, CHC, CHPC) within 5 years of employment.
Must have or be able to obtain by hire a Driver's license.
Strong organizational skills and the ability to manage multiple projects with competing priorities.
Advanced degree (M.S., M.A., Ph.D., M.D., J.D.).
5+ years experience in human subject's research, particularly clinical research or the coordination or regulatory oversight of human subject research.
Current possession of, or ability to obtain, certification as an IRB/Compliance professional (e.g. CIP or CHC, CHPC) within 3 years of employment or current possession of an IRB professional certificate and ability to obtain professional certification within 3 years of employment.
Demonstrated ability to make judgment calls in ambiguous situation.
Demonstrated ability to pay outstanding attention to detail.
Demonstrated ability to write and speak in concise, accurate, and intelligible manner; Demonstrated ability to work independently with minimal supervision.
Demonstrated analytical and problem solving skills.
Ability to act collegiality and demonstrate professional interpersonal skills.
This position has been designated by the department to require a background check.
Applicants must attach the following documents to their online application: 1) resume 2) a cover letter and 3) contact information for professional references. Application materials should clearly communicate how the applicant meets all required qualifications and additional requirements.
Time Type: Full time
Position Term: 12 Month
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 veteran, persons of disability and/or persons age 40 and over are encouraged to apply.
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.
Founded in 1890 in Pullman, Washington State University (WSU) is Washington’s land-grant university with an overarching mission of improving the quality of life for all citizens – locally, nationally, and globally. WSU is committed to innovation and excellence in research and scholarship. WSU has a current enrollment of over 30,000 undergraduate, graduate, and professional students and approximately 6,000 faculty and staff at its five campuses (Pullman, Spokane, Tri-Cities, Vancouver, and Everett), as well as its numerous other locations across the State of Washington and online through its Global Campus.
U.S. News & World Report's 2016 "America's Best Colleges" rankings place WSU in the top 75 public national universities. WSU was one of only three Northwest universities to be placed in the top two tiers, along with the University of Washington and the University of Oregon. WSU is ranked as a "highest research activity" institution by the Carnegie Foundation and is in the top 12 percent of research universities as reported by the National Science Foundation. Also, WSU was recognized by the Carnegie Foundation for the Advancement of Teaching for its engagement activities with i...ts Community Engagement Classification.
WSU employs approximately 6,000 faculty and professional staff and the University deeply values diversity among its faculty, students, and staff. WSU students represent diverse social, economic, and ethnic backgrounds: approximately 10 percent of WSU students hail from outside the state of Washington, and approximately 6.8 percent are international students. WSU annually awards more than $280 million in scholarships and financial aid to approximately 17,000 undergraduate students.