Research Compliance Analyst - SanFrancisco, United States - University of California, San Francisco

Description

M_PEDS-HEMATOLOGY

Full Time

75604BR

Job Summary

The UCSF Alpha Clinic, under the UCSF Department of Pediatrics is seeking a Research Compliance Analyst for its CIRM-funded Alpha Clinic network site. The goals of the alpha clinic (AC) at UCSF are designed to accelerate the tempo of cellular-based clinical trials at UCSF and support investigators at all stages of clinical and preclinical clinical protocol development. The Research Compliance Analyst (RCA) will work closely with the Program Manager to provide infrastructure support to investigators and their teams participating in AC-approved cellular based clinical research. Under general supervision, the Research Compliance Analyst provides regulatory support, startup, and project management for current and pipeline research studies across all trial types. The incumbent interacts with departments/agencies involved in clinical research including HRPP, OCTA, FDA, CIRM, and other regulatory agencies pertinent to clinical research with an emphasis on human subject protection, subject consents, and IRB policies and procedures. The incumbent works closely with various functional areas and study teams in facilitating communications with regulatory agencies and preparing and submitting regulatory documentation. The ideal candidate will use 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. The RCA will be working with a variety of investigators and their research teams to assist in tracking clinical trials throughout the lifecycle of the study, including regulatory submission, budgeting, coverage analysis, study activation, subject enrollment, progress reports, and trial completion.

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 )

Please note: The compensation ranges listed online for roles not covered by a bargaining unit agreement are very wide, however a job offer will typically fall in the range of 80% – 120% of the established mid-point. 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:

Department Description

The UCSF Alpha Clinic provides campus-wide infrastructure support to accelerate the startup time for cell and gene therapy research. Our goal is to ensure continuous movement of all startup and project milestones for cross-bay clinical research. The Alpha Clinic services intersect with campus-wide resources and central activation offices, and as such, have a broad, institutional reach to support cell and gene therapy human research trials.

Required Qualifications

• Bachelor's degree in related area and / or equivalent experience / training
• Minimum 3 years of experience in clinical research
• Demonstrated self-discipline and sound, independent judgment completing complex assignments
• Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents
• Ability to travel to Oakland and other UCWR campus locations
• Excellent interpersonal and communication skills both verbally and in writing. Ability to exercise tact, mature judgment, diplomacy, and flexibility to promote positive working relationships
• Demonstrated ability to organize and prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities
• Strong computer skills and demonstrated knowledge of a variety of software programs (email, word processing, spreadsheet, database applications, Adobe Acrobat, web browsers, VELOS, REDCap, etc.). Ability and willingness to learn new software as needed
• Demonstrated administrative experience with skill to coordinate complex activities and to use independent judgment to organize and prioritize tasks

Preferred Qualifications

• Master's degree in related area and / or equivalent experience/ training
• CCRP Certification
• Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology
• Demonstrated proficiency in public speaking, and writing
• Demonstrated experience producing clinical regulatory documents, including proposals, consents, adverse event reports and close out documents
• Conflict of Interest: Understanding of stock options, consulting agreements and other corporate documents related to research and analysis of potential conflicts of interest
• Working knowledge of UCSF Research systems (OnCore, iMedris, ApEX)
• Working knowledge of SMART IRB

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

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.

Job Code and Payroll Title

006230 RSCH CMPLNC ANL 3

Job Category

Research and Scientific

Bargaining Unit

99 – Policy-Covered (No Bargaining Unit)

Location

Flexible (combination of onsite and remote work), Parnassus Heights (SF)

Additional Shift Details

Monday-Friday, 8:30am – 5:30pm

View or Apply

To help us track our recruitment effort, please indicate in your email – cover/motivation letter where ) you saw this job posting.