Job Description

Payroll Title:
RSCH CMPLNC ANL 2
Department:
CLINICAL TRANSLA RESEARCH INST
Salary Range
Commensurate with Experience
Worksite:
Remote
Appointment Type:
Career
Appointment Percent:
100%
Union:
Uncovered
Total Openings:
1
Work Schedule:
Days, 8 hrs/day, M-F

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

#113604 Regulatory Analyst

Initial Review Date: Thu 1/13/2022

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

Update as of 1/6/22: This position will be primarily remote but will need to work on-site, as needed, approximately 1 - 3 times per month.

UCSD Layoff from Career Appointment: Apply by 01/04/2022 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants: Apply by 01/11/2022. Eligible Special Selection clients should contact their Disability Counselor for assistance.

DESCRIPTION

The Clinical and Translational Research Institute (CTRI), an organized research unit at UCSD, receives partial funding from the National Center for Advancing Translational Science, a component of the National Institutes of Health. The mission of the CTRI is to create an environment that advances healthcare through interactions between basic scientists, clinical investigators, community physicians, and patients. The CTRI also serves as the coordinating center for multidisciplinary educational programs in translational research. It is under the direction of Gary Firestein, MD, Distinguished Professor of Medicine and Senior Associate Vice Chancellor for Health Sciences.

Under general supervision by the Director of the Regulatory Affairs, incumbent will work with the CTRI Research Project Managers and with CTRI partner organization investigators, including Rady Children’s' Hospital, and Sanford Burnham to assist in study initiation and provide regulatory services including administrative support that includes submission of initial clinical research applications, amendments and renewals to the Institutional Review Boards as well as maintenance of regulatory documentation, working with study monitors as well as working with related, collaborating University offices such as Radiation Safety, Biosafety, COI, OCAA and OCTA and external regulatory offices such as independent IRBs. In general, this individual must work independently without minimal supervision or oversight for routine or standard assignments.

Incumbent should have knowledge of HHS-OHRP, FDA, HIPAA regulations as well as Good Clinical Practices (GCP). Knowledgeable about clinical trials administration and regulatory monitoring, IND/IDE submissions. This front line position will generate regulatory documents for member investigators requesting CTRI services from small investigator-initiated projects to large multi-center clinical trials. Interacts frequently with investigators, persons in other organizational departments, as well as with persons outside the University such as industry-sponsor personnel. Interactions require the use of tact and independent judgment, knowledge of standards and best practices. Demonstrate good judgment in selecting methods and techniques for obtaining solutions.

MINIMUM QUALIFICATIONS

  • Six years of related experience, education/training, OR a Bachelor’s degree in related area plus two years of related experience/training.

  • Independence, planning and decision-making abilities to complete assigned duties.

  • Ability to solve problems, issues; listen, interpret and confirm understanding of others' communications; and be objective.

  • Effective, efficient and tactful oral and written communication skills.

  • Time management skills and the flexibility to accommodate changing priorities in unit.

  • Ability to work in a team oriented setting, to prioritize work, and to follow through on routine assignments with minimal direction.

  • Proficiency with computers, including the ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities.

  • Excellent customer service skills, pleasant, helpful and patient.

  • Strong organizational skills, the ability to multi-task, and work with frequent interruptions.

  • Knowledge of the components of clinical trials including study methodology, informed consent, eligibility, and adverse events. Knowledge of clinical research and clinical trials, analyzing and evaluating information for preparation of clinical research protocols.

  • Understanding of the role of clinical research in a major research university and its links with campus, national and international constituencies and industry.

PREFERRED QUALIFICATIONS

  • Relevant compliance certification.

  • Knowledge of relevant Federal and State regulations, and policies.

  • Thorough knowledge and ability to apply all relevant Federal, state regulations, policies, and federal guidance documents. Demonstrated experience working with FDA regulations, OHRP, HIPAA, UC & IRB policies and procedures, Good Clinical Practice guidelines and other regulations for the conduct of clinical research with a strong emphasis in human subject protections.

SPECIAL CONDITIONS

  • Employment is subject to a criminal background check.

  • This will be a primarily remote position but will need to work on-site, as needed, to update physical regulatory binders and to meet with Study Monitors approximately 1 - 3 times per month.

  • Must be able to maintain confidentiality.


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!

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.

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

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!

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