Job Description

Payroll Title:
RSCH CMPLNC ANL 4
Department:
CLINICAL TRANSLA RESEARCH INST
Hiring Salary Range
$63,400.00 - $103,100.00 / Year
Worksite:
La Jolla
Appointment Type:
Career
Appointment Percent:
100%
Union:
Uncovered
Total Openings:
1
Work Schedule:
Days, 8 hour shifts, Monday - Friday

As a federally-funded institution, UC San Diego Health maintains a marijuana and drug free campus. New employees are subject to drug screening.

#119906 Lead QA/QI Regulatory Analyst - Remote

Filing Deadline: Fri 12/2/2022

UC San Diego values equity, diversity, and inclusion. If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly encourage you to apply.

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

UCSD Layoff from Career Appointment: Apply by 11/22/22 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants: Apply by 12/02/2022. Eligible Special Selection clients should contact their Disability Counselor for assistance.

Candidates hired into this position will have the ability to work remotely.

DESCRIPTION

The Altman Clinical and Translational Research Institute (ACTRI) an organized research unit at UCSD, was established to provide education, training and infrastructure for clinical research in the San Diego area. It encompasses four hospital systems, two universities and four biomedical research organizations. It receives partial funding from a Clinical and Translational Science Award (CTSA) from the NIH, National Center for Advancing Translational Science. The ACTRI functions under the direction of Gary S. Firestein, M.D., Director, and Senior Associate Vice Chancellor Health Sciences at UC San Diego.

This position will lead broad efforts to support our continuous quality improvement efforts in clinical & translational research. The incumbent will initially focus on IRB and human research policies and practices in Health Sciences, but will transition to the broader scope relatively quickly. Focus areas include national best practices in IRB operations, policies, and procedures, GCP in research, FDA procedures, and process improvement.

Uses advanced research compliance concepts to interpret highly complex and broad regulations, policies and guidelines. Regularly works on highly complex research compliance issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria to anticipate and identify problems and develop and implement the appropriate response and / or action. Serves as a technical expert and advisor to department head.

MINIMUM QUALIFICATIONS

  • Nine (9) years or more of related experience, education/training, OR a Bachelor’s degree in related area plus five (5) or more years of related experience/training.

  • Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments. Proven experience with successfully developing a QA program, or equivalent; interpreting regulations and developing and implementing policies and procedures.

  • Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents. Demonstrated expert knowledge of research and compliance policies, regulations and guidelines, including but not limited to FDA, OHRP, IRB and NIH.

  • Strong proficiency in public speaking, and writing. Demonstrated success at creating whitepapers, presentations, or equivalent, for broad dissemination to a wide audience.

  • Advanced knowledge of quantitative and qualitative research design, scientific research concepts and terminology.

PREFERRED QUALIFICATIONS

  • Relevant compliance certification (if applicable) preferred.

SPECIAL CONDITIONS

  • Employment is subject to a criminal background check.

Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).

If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.

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!

Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community.

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.

Application Instructions

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