UCSD Layoff from Career Appointment: Apply by 10/11/18 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 10/23/18. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The Department of Medicine is responsible for fulfilling the teaching, research, and clinical missions of the University of California, San Diego and employs 486+ full-time salaried faculty members and 100+ academic appointees. Staff personnel include 600+ staff in 9 bargaining units, students, and volunteers. There are 250 clinical faculty practicing at multiple sites and hospitals.
Under the supervision of the Director of Operations and the AVRC Medical Director, this key professional position is responsible for independent management and oversight for regulatory compliance, project analysis, report compilation for various internal and external information systems and sources the Antiviral Research Center (AVRC) and the Center for AIDS Research (CFAR) in the Division of Infectious Disease, in the Department of Medicine. The AVRC works with several different International sites performing approx 30 distinct clinical trials through a multi-million dollar NIH/DAIDS grant.
The CFAR is a multi-million dollar NIH-DAIDS grant dedicated to the research and development of basic and clinical research of HIV/AIDS by awarding multiple sub-grants to Junior Faculty members in the US and in the developing world. This position requires demonstrated in-depth knowledge of UC, HIPAA, FDA, OHRP, International regulations pertinent to clinical research with a strong emphasis in regulatory submissions to include human subject protections, subject consent and diverse IRB policies applicable at the various domestic and international clinical sites. In addition, this position requires a demonstrated working knowledge of medical terminology and scientific/biological procedures, Conflict of Interest, Good Clinical Practices (GCP), federal research regulations and requirements, clinical trials administration and regulatory monitoring.
This individual serves as a subject matter expert and as a resource reviewer for clinical trials, investigator initiated studies, and grant supported research interpreting regulations for the AVRC as well as for the CFAR faculty, PI's and administrative staff by maintaining up to date knowledge of local, state federal and International regulations as well as HRPP related policies and procedures regarding the protection of human subjects. The incumbent will create subject consent forms and independently reviews and analyzes proposed informed consent documents for consortium participating domestic and international sites; assists in the development, review and distribution of study set-up materials including, but not limited to, subject consent forms, clinical study protocols and regulatory packages.
In addition to managing UCSD's AVRC and CFAR IRB submissions and renewals, will interface and serve as liaison with 14 AVRC clinicians, over 35 CFAR domestic clinicians and 25 International CFAR clinicians and IRBs to ensure protocol approval. Produces impactful, concise, descriptive written reports summarizing analysis results and recommendations, suitable for external advisory board briefings. Conducts difficult negotiations with PI's and the IRB and/or other appropriate bodies, representing the final determinations in an appropriate manner. Supports AVRC and CFAR strategic planning and decision making through the in-depth analysis, presentation and distribution of AVRC and CFAR research data.
Uses skills as a seasoned, experienced research compliance professional with a full understanding of industry practices and organization policies/procedures to apply federal, state, and university regulations, policies, and guidelines, and promote best practices. Interacts frequently with investigators, persons in other organizational departments, and occasionally persons outside the University. Interactions require the use of tact and independent judgment, knowledge of standards and best practices, and counseling to resolve a wide range of research compliance issues. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Errors or omissions may ultimately place research participant at undo risk and/or compromise the institution's assurance of regulatory compliance with the federal government.
A Bachelor's Degree in related area; and/or equivalent experience/training.
A minimum of three (3+) or more years of relevant experience.
Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documen
UC San Diego is an academic powerhouse and economic engine, recognized as one of the top 8 public universities by U.S. News and World Report. Innovation is central to who we are and what we do. Here, students learn that knowledge isn't just acquired in the classroom - life is their laboratory. UC San Diego's rich academic portfolio includes six undergraduate colleges, five academic divisions and five graduate and professional schools. The university's award-winning scholars are experts at the forefront of their fields with an impressive track record for achieving scientific, medical and technological breakthroughs.