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REGULATORY AFFAIRS COORDINATOR

Employer
University of California-Irvine
Location
Irvine

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Job Details



University of California Irvine

REGULATORY AFFAIRS COORDINATOR



Updated: Jan 5, 2021
Location: UC Irvine Campus
Job Type:
Department: CANCER CENTER

Job Opening ID: 12904

Reports To: CLIN RSCH MGR 1

Working Title: REGULATORY AFFAIRS COORDINATOR

Department: CANCER CENTER

Bargaining Unit: RX

FLSA: Non-Exempt

Payroll Job Code: 009335

Job Location: UCI Campus- Irvine

Percent of Time: 100%

Work Schedule: 8-5, M-F

Employee Class: Career

Position Summary:

Under the supervision of the Regulatory Program Manager (RPM) of the Regulatory Affairs Unit, the Regulatory Affairs Coordinator (RAC) supports the clinical research efforts of the Chao Family Comprehensive Cancer Center by providing comprehensive, regulatory management of cancer-related protocols in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and University policies and procedures. The NCI-designated Chao Family Comprehensive Cancer Center (CFCCC) is a campus-wide multidisciplinary matrix organization whose goal is to promote and enhance cancer-relevant research and patient care at UC Irvine. The CFCCC provides research resources to its ~175 members engaged in research and offers multidisciplinary cancer care to its patients. Responsibilities related to regulatory coordination activities include independently managing and preparing submissions of new studies, modifications, renewals, adverse events, and study closures to the Institutional Review Board (IRB), Food and Drug Administration (FDA) and other ancillary committees including, but not limited to, Disease-Oriented Teams (DOTs), Protocol Review and Monitoring Committee (PRMC), Data and Safety Monitoring Board (DSMB), Institutional Biosafety Committee (IBC), Radiation Safety Committee (RSC), and Epidemiology Infectious Prevention (EIP). The RAC is responsible for effectively shepherding protocols through the regulatory committee process in a timely manner to ensure activation of trial and for all regulatory aspects of the protocols assigned. In addition, the RAC serves as the liaison to sponsors, governing agencies and facilitates transmission of verbal and written communication to National Clinical Trials Network (NCTN) groups, pharmaceutical companies, and other research entities as needed. The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors. The incumbent must accurately maintain regulatory information in the clinical trial management system (OnCore) and adhere to institutional policies and external Cancer Center Support Grant guidelines for reporting to the National Cancer Institute (NCI).

Compensation Range:

$29.11 - $37.39

Department Website:

http://www.cancer.uci.edu/

Required:

3 to 5 years of related work experience with a Bachelor of Arts/Bachelor of Science, or equivalent experience. Experience with submitting to various institutional research committees, i.e., Institutional Review Board, Protocol Review Monitoring Committee, Data Safety Monitoring Board, Institutional Biosafety, Radiation Safety Committee, and Epidemiology Infectious Prevention. Ability to interact with the public, faculty, and staff. Ability to establish and maintain files and records. Access to transportation to off-site research locations. Willingness to work as a supportive, cooperative member of an interdisciplinary team. Demonstrated high-level communication skills to convey information in a clear and concise way, synthesizing information and presenting it to others. Demonstrated problem solving capabilities to resolve concerns that arise unexpectedly. Demonstrated ability to research, properly evaluate information, and prepare concise, well organized reports, summaries, and correspondence. Demonstrated ability to organize and prioritize a complex and dynamic workload. Ability to multitask and meet deadlines, despite interruptions. Ability to independently exercise discretion and sound judgment. Ability to work collegially and cooperatively in a small office and to establish and maintain cooperative working relationships. Demonstrated skill in interacting with persons of various social, cultural, economic and educational backgrounds. Ability to prioritize assignments and achieve high productivity/quality with short time frames, under rigid deadlines, and/or in environments with frequent workload changes and competing demands. Skill in working independently, taking initiative and following through on assignments. Ability to think critically, compiles data from various sources, analyze data, and prepare reports. Ability to work both independently and as part of team. Ability to take initiative and demonstrate strong commitment to duties. Ability to perform ongoing needs analysis and recommend solutions to resolve concerns. Ability to work within a deadline-driven structure. Demonstrated experience in maintaining flexibility and adaptability while implementing institutional change. High level of integrity and honesty in maintaining confidentiality. Foster and promote a positive attitude and professional appearance. Strong attention to detail. Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint).

Preferred:

Experience with cancer-related research. Knowledge with various types of human subject clinical trials (i.e., National Group, Industrial, and Investigator-authored). Experience with clinical trial management systems, preferably OnCore.

Special Conditions Required:

May require study management coordination outside of normal business hours. May require travel to satellite sites.

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.

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.

UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500.


To apply, visit https://careersucirvine.ttcportals.com/jobs/5869439-regulatory-affairs-coordinator





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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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