Manager, CTSS - 120071
#120071 Manager, CTSSFiling Deadline: Wed 2/8/2023
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
Placement within the range is determined by internal equity, relevant qualifications, and collective bargaining agreements (when applicable).
UCSD Layoff from Career Appointment: Apply by 1/27/2022 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 2/8/2022. Eligible Special Selection clients should contact their Disability Counselor for assistance.
This position will remain open until a successful candidate has been identified.
Candidates hired into this position will have the ability to work a remote or hybrid schedule.
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. The unit is under the direction of Gary Firestein, MD, Distinguished Professor of Medicine and Senior Associate Vice Chancellor for Health Sciences.
The Clinical Trial Support Services (CTSS) Manager works under the general supervision of the Chief Administrative Officer of the ACTRI. The CTSS Manager provides on-going administrative management, problem resolution services, and functions as a resource and advisor to the CTSS team, Investigators and Project Managers. The incumbent acts in the absence of, or on behalf of the Director for resolution of management issues, policy interpretation, and problem resolution within the functional areas of expertise. Interactions require the use of tact and independent judgment, knowledge of standards and best practices.
The CTSS Manager independently, supervises the CTSS professional staff to accomplish the tasks necessary for effective regulatory management of human subjects research/clinical research regulatory submissions for small investigator-initiated projects as well as large multi-center clinical trials. Principal Investigators often require site pre-qualification support, study monitor support, in addition to regulatory submission support throughout the lifecycle of the research.
The incumbent also works closely with related, collaborating University offices such as the IRB, Radiation Safety, Biosafety, COI, OCAA and OCTA and external regulatory offices as well as as independent IRBs to facilitate clinical research at UCSD and at our CTRI partner organizations, including Rady Children’s' Hospital, and Sanford Burnham. The CTSS Manager will have working knowledge of HHS-OHRP, FDA, HIPAA regulations as well as Good Clinical Practices (GCP) and will have knowledge of clinical trials administration and regulatory monitoring, as well as FDA IND/IDE submissions.
The incumbent also provides FDA regulatory guidance and support to faculty seeking FDA 510K/IDE/IND approval for medical devices or drugs. This often involves submission of requisite documentation to support a pre-submission meeting with the FDA to confirm the regulatory approval pathway as well as submission of documentation to support FDA marketing approval. CTSS also provides support for submission of FDA Annual Reports.
In addition, the CTSS Manager will know every facet of CTSS office operations to efficiently perform the work of any staff on leave.
Uses advanced research compliance concepts to interpret highly complex and broad regulations, policies and guidelines. Regularly works on highly complex regulatory 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 within the functional areas of expertise to Principal Investigators and others in CTRI units.
Nine years of related experience, education/training, OR an Bachelor’s degree in related area plus five years of related experience/training.
Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments.
Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents.
Advanced knowledge of quantitative and qualitative research design, scientific research concepts and terminology.
Strong proficiency in public speaking, and writing.
Bachelor's degree with a major in a relevant area and five years of experience in administrative analysis or research operations; or an equivalent combination of education and experience.
In depth knowledge of federal regulations of FDA and OHRP regulations.
Strong interpersonal skills - particularly regarding sensitive issues. Skill in communicating with people of diverse cultural and educational backgrounds. Demonstrated ability to exercise judgment, tact, and firmness with faculty, staff, and students.
Ability to utilize multiple resources and references in order to understand complex regulations and scientific issues. Strong analytical and problem-solving skills.
Excellent written communications skills in work for publication, letters, memos, and electronic mail.
Ability to make quick, informed decisions regarding complex issues.
Able to work independently and effectively under tight deadlines.
Employment is subject to a criminal background check.
Must be able to maintain confidentiality.
Pay Transparency Act Full Salary Range: $63,400 - $142,800 Annually
The University of California, San Diego is required to provide a reasonable estimate of the compensation range for this role. This range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be offered a salary at or near the top of the range for a position. Salary offers are determined based on final candidate qualifications and experience. The full salary range for this position is defined as the Full Pay Range. The budgeted salary or hourly range that the University reasonably expects to pay for this position defined as the Expected Pay Scale. Placement within the Expected Pay Scale is determined by internal equity, relevant qualifications, and collective bargaining agreements (when applicable).
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!
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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
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