Regulatory Affairs Analyst

San Francisco, CA, United States

Regulatory Affairs Analyst

Helen Diller Family Comprehensive Cancer Center (HDFCCC)

Full Time

78772BR

Job Summary

The Regulatory Affairs Analyst will support and obtain human subjects and safety committee approvals for oncology clinical trials supported by the HDFCCC CRSO.

The analyst works independently, under the direction of the Regulatory Affairs Manager, to review cooperative and industry-sponsored protocols, revise local informed consents (ICFs), and submit review packets (protocols, ICFs, and other required documents) to the UCSF IRB and external IRBs.

The analyst will ensure that the trials are in compliance with federal, state, UCOP, and UCSF mandated laws, regulations, and policies pertinent to research involving human subjects.

Day to day tasks include:

Assist Regulatory Affairs Manager with work request triage prior to weekly assignment distribution.

Accept regulatory assignments each week as assigned by the Regulatory Affairs Manager.

Volunteer for work assignments that are deemed time sensitive and are outside of the weekly assignment schedule.

Revise ICFs for current trials on sponsor templates by incorporating HDFCCC template language.

Collaborate with study submitters to receive Radiation Safety Committee (RSC) approval.

Create, modify, and submit the IRB review application(s) and packet(s) for Initial study reviews (External IRB only)

Monitor, triage and address stipulations received from IRB by communicating with study submitters, sponsors and the IRB, to finalize the submission and gain approval. Will communicate needs to the Regulatory Affairs Manager when communication has not been received from the appropriate party within one week of request.

Review ICF changes for studies relying on external IRB to ensure required institutional language is included and edit the ICFs when needed to gain approval.

Deliver prompt and clear communications with counterparts in the regulatory unit, study teams, sponsors, IRBs, and various constituent groups within the Helen Diller Family Comprehensive Cancer Center (HDFCCC).

The final salary and offer components are subject to additional approvals based on UC policy.

To see the salary range for this position (we recommend that you make a note of the job code and use that to look up): TCS Non-Academic Titles Search (https://tcs.ucop.edu/non-academic-titles)

Please note: An offer will take into consideration the experience of the final candidate AND the current salary level of individuals working at UCSF in a similar role.

For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range.

To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html

Department Description

This position is housed in the Clinical Research Support Office (CRSO), a centralized clinical trial management office in the UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC), which provides project management and clinical research coordinator staff, and regulatory services for oncology related clinical trials.

The HDFCCC is one of only two cancer centers in the Bay Area to hold the prestigious designation of "comprehensive" from the National Cancer Institute (NCI). We integrate the work of researchers and clinicians dedicated to four fundamental pursuits: laboratory research into the causes of cancer progression; clinical research to translate new knowledge into viable treatments; compassionate, state-of-the-art patient care; and population research that can lead to improvements in prevention, early detection, and quality-of-life for those living with cancer. The twin pillars of precision medicine and precision population health guide research and treatment at HDFCCC.

Required Qualifications

Bachelor's degree in related area and / or equivalent experience / training.

Minimum of one year of related experience.

Ability to solve problems, issues; listen, interpret and confirm understanding of others' communications; and be objective.

Effective, efficient and tactful oral and written communication skills.

Time management skills and the flexibility to accommodate changing priorities in unit.

Ability to work in a team oriented setting, to prioritize work, and to follow through on routine assignments with minimal direction.

Proficiency with computers, including the ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities.

Excellent customer service skills, pleasant, helpful and patient.

Independence, planning and decision-making abilities to complete assigned duties.

Strong organizational skills, the ability to multi-task, and work with frequent interruptions.

Preferred Qualifications

Relevant compliance certification (if applicable) preferred (RAC, SoCRA, CCRP, PMP, etc).

Previous exposure to regulatory submissions such as human subjects (IRB), Food and Drug Administration (FDA), BioSaftey (BUA) or Radiation Safety (RSC).

Knowledge of relevant Federal and State regulations, and policies.

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 (Non-Clinical), Research and Scientific

Bargaining Unit

99 - Policy-Covered (No Bargaining Unit)

Employee Class

Career

Percentage

100%

Location

Flexible (combination of onsite and remote work), Mission Bay (SF)

Shift

Days

Shift Length

8 Hours

Additional Shift Details

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