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Research Compliance Principal Analyst

Job Details



University of California, Irvine

Research Compliance Principal Analyst


Perform comprehensive audits of research activities for IRB-approved research protocols conducted at the UCI Medical Center, UC Irvine campus and other non-University sites, analyzing research documentation including research contracts, protocols, consents and agreements, and electronic support systems, e.g. UCIMC-EMR, CTMS, etc. to ensure compliance with federal and state regulatory requirements. Provide written audit findings with analysis, develop corrective action and refer corrective action plans to appropriate research personnel and departmental leadership. Design and revise audit review program to ensure compliance with changing regulatory directives. Independently lead special investigations compliance initiatives.
Identify research compliance risks in Clinical Trial Billing, Human Research Protections (informed consent, IRB, ethics, meeting inclusion/exclusion requirements), FDA regulations (sponsor-investigators, GMPs, etc.), Conflicts of Interest (including fraud and abuse), HIPAA Privacy and Security and provide regulatory advice and oversight to ensure that clinical research is conducted in compliance with established federal guidelines, state statutes, Joint Commission Standards, University policy, and UCIMC clinical policy and procedures. Develop UCI policies and procedures to improve research compliance and educate investigators and staff on new or revised federal guidelines and state statutes to ensure compliance.
Develop educational materials, present educational information to groups and assist in staff training to enhance clinical research outcomes.
Maintain detailed lines of communication [written or verbal] regarding the audit and investigation process with the Chief Compliance & Privacy Officer, Deputy Compliance Officer, Research Compliance Officer, investigators, and administrative staff and the Office of Research Administration.
Independently and in coordination with the Office of Research Affairs, conduct investigations of research misconduct as directed in the Public Health Service Policies on Research Misconduct and in accordance with the UC Whistleblower Policy.

The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy.

Salary: Monthly $5,463.67 - $7,452.67
Total Hours: 8-5, M-F
Career Position.
May be required to work beyond Monday-Friday, 8:00 a.m. to 5:00 p.m. or on weekends. Will be required to travel between the Medical Center in Orange and the Irvine campus.
Final candidate subject to background check.
As a federal contractor, UC Irvine is required to use E-Verify to confirm the work status of individuals assigned to perform substantial work under certain federal contracts/subcontracts.
Please attach your resume.

Click here to see the Som - Compliance website.

View Job Description for the position requirements.


To apply, visit https://staffing2.hr.uci.edu/CSS_External/CSSPage_Referred.ASP?Req=2019-0290





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Organization

Founded in 1965, UC Irvine combines the strengths of a major research university with the bounty of an incomparable Southern California location. Over five remarkable decades, UCI has become internationally recognized for efforts that are improving lives through research and discovery, fostering excellence in scholarship and teaching, and engaging and enriching the community.UC student center

With more than 33,000 students, 1,200 faculty members and 10,000 staff, UCI is among the fastest-growing campuses in the University of California system. Increasingly a first-choice campus for students, UCI ranks among the top U.S. universities in the number of undergraduate applications and continues to admit freshmen with highly competitive academic profiles. Orange County’s second-largest employer, UCI generates an annual economic impact on the county of $5 billion.

UCI is a center for quality education that honors classic instruction while incorporating the best new scholarship. U.S. News & World Report consistently ranks UCI among the nation’s best universities. Achievements in the sciences, social sciences, social ecology, arts, humanities, medicine and business also have garnered numerous national rankings for UCI’s schools, departments and programs. Three UCI researchers have won Nobel Prizes – most recently Irwin Rose, in chemistry, in 2004.

Interdisciplinary research, a UCI hallmark, is evident in the California Institute for Telecommunications and Information Technology, or Calit2, Newkirk Center for Science and Society, Center for the Study of Democracy, Institute of Transportation Studies, Institute for Genomics and Bioinformatics, and innovative instructional programs in biomedical engineering, international studies, global cultures, arts and technology, and other collaborations.

The university is dedicated to excellence through diversity and to the goal of reflecting equity and inclusion in our faculty, staff and student populations. Faculty and staff diversity affinity groups foster cross-departmental social interaction, professional networking, cultural competencies, recruiting and mentoring.

Committed to the Community

UCI reaches beyond the classroom and laboratory to help solve societal issues and support human development. In the health sciences, UCI is noted for its research on cancer, the neurosciences and the genetic underpinnings of disease. UCI Medical Center, Orange County’s only university hospital and Level I trauma center, has been ranked among the nation’s best hospitals by U.S. News & World Report for 16 consecutive years.

UC Irvine parkA major intellectual and cultural center, UCI engages the community through public activities and events. Speakers on campus, for example, have included Nobel Peace Prize winners His Holiness the XIV Dalai Lama, former Soviet leader Mikhail Gorbachev and Iranian human rights activist Shirin Ebadi, all of whom also received the UCI Citizen Peacebuilding Award for their efforts toward world peace.

The university is also addressing the needs of the community and growing world population in an environmentally sustainable way. From the development of new and reliable processes for electricity and alternative fuels to critical water and waste management solutions, UCI consistently tops the list in Sierra magazine’s “Coolest Schools” report, its annual sustainability ranking of U.S. colleges and universities.  

A hub for innovation and entrepreneurship, the university collaborates with the community on many strategic partnerships such as UCI Applied Innovation , a center which brings campus-based discoveries together with Orange County’s vibrant business sector to support job creation and economic growth. Development also continues on the 185-acre University Research Park adjacent to campus, where R&D companies enjoy collaborative opportunities in medical research, biotechnology, engineering, computer science and business.

UCI is benefiting the community and the world in countless ways through its scholarly, scientific, creative and economic contributions. On its way to becoming a flagship UC campus and one of the nation’s very best universities, UCI has embarked on a strategic plan that will ensure the campus continues to inspire excellence as it fulfills its research, teaching and public service missions in the decades ahead.

Company info
Website
Telephone
949-824-5011
Location
University of California, Irvine
Irvine
CA
92697
US

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