Regulatory Analyst - 137899

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.

Cardiovascular clinical research represents one of the largest and most complex research portfolios within the department, often encompassing more than 100 active studies at any given time. These projects span a wide spectrum-from early-phase device innovation and interventional trials to heart failure therapeutics, imaging, electrophysiology, prevention, gene therapy, and long-term outcomes research. The breadth and volume of this portfolio require not only robust operational infrastructure but also specialized compliance and regulatory oversight, led in part by a dedicated compliance analyst/regulatory analyst. This role is critical in ensuring adherence to FDA, ICH-GCP, IRB, and institutional requirements; monitoring regulatory submissions and approvals; reviewing study documentation for accuracy and readiness; and proactively identifying areas of risk or noncompliance before they impact research activities. With more than 100 active projects moving simultaneously, the expertise of a compliance/regulatory analyst is essential to maintaining the integrity, safety, and audit-readiness of the entire cardiovascular research enterprise.

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.

• 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.

• Relevant compliance certification (if applicable) preferred.

• Employment is subject to a criminal background check.

If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements.

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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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.

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.

For the University of California's Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination

UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.

UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening.

Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts an offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; or have filed an appeal of a finding of substantiated misconduct with a previous employer.

a. "Misconduct" means any violation of the policies governing employee conduct at the applicant's previous place of employment, including, but not limited to, violations of policies prohibiting sexual harassment, sexual assault, or other forms of harassment, or discrimination, as defined by the employer. For reference, below are UC's policies addressing some forms of misconduct:

• UC Sexual Violence and Sexual Harassment Policy
• UC Anti-Discrimination Policy
• Abusive Conduct in the Workplace