Clinical Trials Regulatory Research Associate - 112526
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#112526 Clinical Trials Regulatory Research AssociateExtended Review Date: Tue 1/25/2022
For the safety and well-being of the entire university community, the University of California requires, with few exceptions, that all students, faculty and staff be vaccinated against the COVID-19 virus and influenza before they will be allowed on campus or in a facility or office. For more information visit: Flu Vaccine Mandate / COVID Vaccine Policy
This position will remain open until a successful candidate has been identified.
UCSD Layoff from Career Appointment: Apply by 10/29/2021 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 11/09/2021. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The UCSD Moores Cancer Center (MCC) is one of only 40 National Cancer Institute-designated Comprehensive Cancer Centers in the United States. This designation is reserved for cancer centers with the highest achievements in cancer research, clinical care, education, and community contributions. Moores Cancer Center strives to stay at the forefront of emerging cancer research in a patient centric environment. Principal Investigators (PIs) in the MCC conduct clinical trials to test new treatments for people affected by cancer. The goal is to find better ways to prevent cancer, treat cancer, and care for cancer patients. The disease teams at the MCC aim to expand the opportunities for advanced therapeutic studies to be written, opened, and maintained, and to increase the number of cancer patients enrolled clinical trials. The focus of the research is cancer symptom intervention studies with an emphasis on novel drug development.
The Clinical Trials Office (CTO) at the Moores UCSD Cancer Center administers many clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators. The Clinical Trials Regulatory Research Associate is responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted by investigators at the Cancer Center. Key to this role is the preparation of clinical trial protocols and related regulatory documents for submission to the UCSD Human Research Protections Program (UCSD's Institutional Review Board or IRB) in order to obtain its approval for the clinical trials to proceed. The Regulatory Research Associate will act as a resource to investigators and staff for interpretation and execution of complex clinical research regulations, policies & procedures concerning the conduct of clinical trials, including those of the FDA, HHS, UCSD IRB, and the CTO. This position requires regular interaction with a variety of internal and external contacts including Cancer Center investigators and staff, UCSD IRB staff, study sponsors and/or their representatives.
Knowledge of medical and pharmaceutical terminology and concepts, as well as theoretical knowledge and/or Bachelor's degree and/or equivalent education and/or experience in a field related to biological sciences as needed to work in Regulatory Affairs.
Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research.
Experience creating Informed Consent Documents that comply with HRPP/UCSD IRB policies and procedures, FDA regulations, and sponsor requirements.
Experience preparing various forms, documents, and reports, such as Investigational Drug Fact Sheet, New Study Applications, Renewal Applications, IND Applications, etc. Experience preparing, reviewing, and understanding clinical research protocols and protocol amendments.
Proven knowledge or related experiences to comprehend, interpret, and apply regulations and legislation regarding the protection of human subjects. These include regulations under federal policies, FDA, and other compliance agencies or directive.
Experience using standard word processing and data management software programs, including Word and Excel, in order to develop and prepare reports.
Excellent interpersonal, as well as written and oral communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness.
Experience with editing, including summarizing information into concise and condense documents.
Proven ability to determine sources of information and data, and to analyze the data and information obtained, in order to create documents and to propose solutions to issues. Detail oriented, logical, and methodological approach to problem solving.
- Working knowledge of UCSD Human Research Protections Program (HRPP/IRB) policies and Procedures.
- Knowledge of oncology and hematology.
- Employment is subject to a criminal background check and pre-employment physical.
- Must complete annual TB screen.
- Must be able to maintain strict confidentiality.
- Must be available to work occasional evenings and weekends (may include attending PRMC meetings twice per month, as needed).
Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).
UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!
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UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html
UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.