Regulatory Analyst - #196320

University of California San Francisco


Date: 06/08/2022 04:30 AM

City: San Francisco, California

Contract type: Full Time

Work schedule: Full Day






Under the supervision of the Senior Regulatory Supervisor, the
Regulatory Analyst will monitor regulatory communications and manage work assignments from CRSO study teams; manage IRB submissions and approvals; update a database system; and provide regulatory support for the CRSO study teams



Using research compliance concepts, applies organization policies and procedures to review and / or pre-review moderately complex, minimal risk research protocols. Works independently in most cases without a great deal of supervision or oversight for routine or standard assignments. Occasionally pre-reviews or highlights potential issues of concern for department head or full committee to consider in their review of research protocols that qualify for full committee review





Department Description



The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) combines basic science, clinical research, epidemiology, cancer control and patient care from throughout the University of California, San Francisco system. The centralized Protocol Development and Regulatory Affairs unit provides support to HDFCCC faculty and the disease programs to obtain regulatory approvals for translational and clinical research focused on the development of safe and efficacious therapeutic agents.



The HDFCCC is a fast-paced environment. A successful candidate will be independent, detail-oriented with drive and focus, and a team player who consistently delivers results within designated timelines. The incumbent is expected to meet departmental standards and maintain a high level of customer service. Effective time management skills and a high degree of accuracy and detail is necessary for success. This position functions as a source of communication between the IRB, the various research program personnel and faculty within the HDFCCC





Required Qualifications




  • Bachelor's degree in related area and / or equivalent experience / training
  • 1 - 3 years related experience
  • Knowledge of relevant Federal and State regulations, and policies.
  • Proficiency with computers, including ability to operate personal computer software (for example, Word, Access and Excel, email, electronic calendaring, internet, et cetera) with sophisticated retrieval, storage, and merging capabilities.
  • Excellent customer service skills, pleasant, helpful and patient.
  • Time management skills and the flexibility to accommodate changing priorities in unit.
  • Effective, efficient and tactful oral and written communication skills.
  • Ability to work in a team oriented setting, to prioritize work, and to follow through on routine assignments with minimal direction.
  • Strong organizational skills, the ability to multi-task, and work with frequent interruptions.
  • Ability to problem solve issues; listen, interpret and confirm understanding of others' communications; and, to be objective.
  • Independence, planning and decision-making abilities to complete assigned duties.




Preferred Qualifications




  • Relevant compliance certification (if applicable) preferred.
  • Training and/or equivalent experience with clinical trials, regulatory (IRB), and/or healthcare.
  • Training in human subjects and/or good clinical practices.
  • A working knowledge of medical terminology and proven ability to communicate effectively in verbal and written mediums.
  • Proficiency in Adobe and Visio.
  • Familiarity or willingness to learn UCSF trial applications such as iRIS and Oncore.




About UCSF



The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world’s leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells



Pride Values



UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence – also known as our PRIDE values.



In addition to our PRIDE values, UCSF is committed to equity – both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu



Join us to find a rewarding career contributing to improving healthcare worldwide



Equal Employment Opportunity



The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information



Organization



Campus



Job Code and Payroll Title



006229 RSCH CMPLNC ANL 2



Job Category



Professional and Managerial, Research and Scientific, Supervisory / Management



Bargaining Unit



99 - Policy-Covered (No Bargaining Unit)



Employee Class



Career



Percentage



100%



Location



Hybrid-Remote, Mission Bay (SF)



Shift



Days



Shift Length



8 Hours



Additional Shift Details



Monday - Friday; 8:00 AM - 5:00 PM

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