Regulatory and Compliance Specialist – Division of HIV, Infectious Diseases and Global Medicine

MED-ZSFG-AIDS

Full Time

76584BR

Job Summary

Uses skills as a seasoned, experienced professional with a full understanding of analytical practices, policies and procedures; industry practices and organization policies / procedures to apply federal, state, and university regulations, policies, and guidelines, and promote best practices.. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Primarily deals with policies, programs and proposals which are complex in nature and diverse in scope. Interacts frequently with investigators, persons in other organizational departments, and occasionally persons outside the University. Interactions require the use of tact and independent judgment, knowledge of standards and best practices, and counseling to resolve a wide range of research related 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.

The Project Policy Analyst (PPA) will be responsible for administering regulatory activities for multiple industry and government funded studies. The incumbent will work with principal investigators on UCSF and sponsor regulatory submissions including but not limited to initial, modification and renewal submissions to the UCSF The Human Research Protection Program (HRPP/IRB), Institutional Biosafety Committee (IBC), and Office of Clinical Research. The PPA is responsible for site initiation activities, as well as arranging and managing study monitoring visits, and working with internal and external teams to ensure all local and sponsor policies are observed. The incumbent will work with the research team to ensure adequacy, accuracy, and legitimacy of data and monitoring reports. S/He will also be responsible for troubleshooting data-related problems and work with the research team to make maintenance or modifications to the database. The incumbent will assist with generating reports and data extraction as needed.

The PPA will develop a working knowledge of study protocols and investigational products. The incumbent will be responsible for creating study procedure and monitoring manuals and conducting routine monitoring visits for multiple industry and government funded studies. The incumbent will conduct a variety of monitoring activities intended to facilitate and assure that studies comply with the requirements of the approved study protocol, the UCSF IRB, and applicable Food and Drug Administration (FDA) and other regulatory requirements. The incumbent will review study related processes and regulatory activities and create and use monitoring checklists and report templates to record and report monitoring findings. The incumbent will work cooperatively with research staff and investigators to address concerns and to communicate findings that can lead to improved study performance and/or compliance. The incumbent will maintain a record of all correspondence, monitoring reports and other written documentation in accordance with operating procedures.

The PPA will also be responsible for setting up and maintaining project infrastructure. This includes setting up new contracts, submitting PO requests and working with vendors, submitting, maintaining and troubleshooting study invoices and reimbursements. The incumbent will work closely with the PIs and study team to review new requests and media requirements.

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 (ucop.edu)

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

The Division of HIV, Infectious Diseases and Global Medicine at the University of California San Francisco (UCSF) is an internationally recognized global leader in clinical care, research, and education. With its home-base located at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG), the Division has been ranked as the top facility in the country for AIDS care since 1983. The Division’s work is featured frequently in the media, and it is often visited by numerous international, national, state, and local dignitaries and delegations. The Division consists of approximately 36 faculty members, 11 fellows/postdoctoral scholars and 170 academic and staff employees. It is the largest Division of the Department of Medicine (DOM) at ZSFG, with a total expenditure budget of approximately $52 million dollars.

Required Qualifications

• Bachelor’s degree in related area and three-plus (3+) years of related experience and / or equivalent experience / training
• Knowledge of common organization- or research-specific and other computer application programs
• Strong communication and interpersonal skills to communicate effectively, both verbally and in writing
• Ability to use discretion and maintain all confidentiality
• Analytical / problem-solving skills
• Strong skills in analyzing, researching and synthesizing large amounts of data for preparing sound and relevant proposals / analyses
• Ability to multi-task with demanding
• In-depth knowledge of clinical research grants, clinical trials, protocols, regulatory requirements, and complex visit structures
• Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology
• Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents
• Computer literacy, including proficiency using Apple and PC computers, Microsoft Word, Excel, PowerPoint, and Outlook

Preferred Qualifications

• Working knowledge of UCSF business processes including pre- and post-award contracts and grants, academic and staff personnel, and overall UCSF policies and procedures
• Strong policy analysis techniques
• Academic background and experience in HIV and COVID-19

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.

Job Code and Payroll Title

007398 PROJECT POLICY ANL 3

Job Category

Administrative Support, Professional (Non-Clinical), Research and Scientific

Bargaining Unit

99 – Policy-Covered (No Bargaining Unit)

Location

Flexible (combination of onsite and remote work), Zuckerberg San Francisco General (ZSFG)

Additional Shift Details

Monday-Friday