Research - Laboratory/Non-Laboratory, Staff/Administrative
UCSD Layoff from Career Appointment: Apply by 06/09/21 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 06/21/21. Eligible Special Selection clients should contact their Disability Counselor for assistance.
Independently conducts audits of research protocols and associated research documents for compliance with federal, state, and University mandated laws, regulations, and policies. Conduct special complex reviews for allegations of research/clinical trials noncompliance, high risk or best practice areas that require complete analysis of the issue(s), gathering data and evaluation of potential solutions; participate in areas of faculty and staff education, communication, policy development, identification and assessment of areas of research compliance risk for UCSD as well as recommending and ensuring appropriate corrective actions, and provide complex written reports of research compliance activities and trends.
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 promotes best practices.
Interacts frequently with investigators, persons in other organization departments and occasionally persons outside the University that will 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.
Seven (7) years of related experience, education/training working with human subjects research protocols, OR a Bachelor's degree in related area plus three (3) years of related experience/training working with human subjects research protocols.
Strong analytical ability.
Thorough experience with professional oral and written communication.
A self-starter with demonstrated self-discipline, flexibility and sound independent judgment completing complex assignments.
In depth knowledge of research, federal regulations, state laws, site practices and University policies regarding research/clinical trials.
Relevant compliance or research certification.
Experience auditing and monitoring research protocols/clinical trials.
Experience with UC San Diego systems, and development of policies and procedures.
Must be able to work various hours and locations based on business needs.
Employment is subject to a criminal background check and pre-employment physical.
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.