Regulatory Coordinator

Job Summary

The Regulatory Coordinator will provide support within the Administrative Core as the coordinating center for Transforming Research and Clinical Knowledge (TRACK) in Trauma Brain Injury Network (TRACK-TBI NET) a research consortium composed of 18+ US Level 1 Trauma centers that conduct TBI clinical research both under independent and federal regulatory supervision.

The position will collaborate across the functional cores of TRACK-TBI NET, under the supervision and guidance of the Clinical Trial Manager and/or Principal Investigator. The Regulatory Coordinator will interact with different UCSF team members, committees, collaborating sites, and industry/federal partners.

The Regulatory Coordinator must demonstrate exacting knowledge and compliance with UCSF policies, TRACK-TBI NET policies, ICH GCP, SOPs, regulatory agency policies, and documentation requirements, along with other applicable policies of funders and collaborators.

The Regulatory Coordinator should have experience in clinical trial project and regulatory management and be a critical thinker, capable of problem solving, with the ability to manage multiple timelines and submission schedules, communicate regulatory requirements and deadlines to the Administrative Core Leadership and PI, and be amenable to taking on complex responsibilities.

Day-to-day tasks include, but are not limited to:
•          Communication with PI, Admin Core personnel, UCSF support teams, and TRACK-TBI NET leadership (e.g., email, phone, video remote, in person)
•          Assist in leading and managing clinical trials across multiple methodologic and design styles (e.g., observational, drug, and device)
•          Assist in reviewing and modifying study-related documents
•          Assist in IRB and other regulatory submissions (e.g. iRIS, WCG, Advarra)
•          Assist in reviewing budgets and contracts, and supporting documents.
•          Assist in in collecting and reviewing participating sites’ regulatory and other trial documents
•          Highlight potential regulatory (federal and local) issues and design resolutions for these issues
•          Provide guidance to team members and collaborating sites
•          Capacity to work across different platforms and systems

Interest in TBI/neurologic conditions and regulatory requirements associated with clinical trials in this space would be appreciated.

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

Within the Department of Neurological Surgery, the Brain and Spinal Injury Center (BASIC) is a large clinical and research division with over 40 physicians, nurses, research faculty, staff and trainees at the ZSFG Hospital campus. Many colleagues from other departments, other universities throughout the US, and other countries form an active group of investigators and staff with whom we collaborate. The incumbent will serve as a member of BASIC with emphasis on the TRACK-TBI NET projects and also support the spinal cord injury (SCI) clinical research teams.

Required Qualifications

• Bachelor's degree in related area (e.g., life science, health science or related) and/ or equivalent experience / training
• 1+ years of related experience
• Experience in project management or clinical research, or related experience.
• Knowledge of HIPAA and IRB processes
• Strong organizational skills, the ability to multi-task, and work with frequent interruptions.
• Excellent customer service skills, pleasant, helpful and patient.
• Proficiency with computers, including the ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities.
• Ability to work in a team oriented setting, to prioritize work, and to follow through on routine assignments with minimal direction.
• Time management skills and the flexibility to accommodate changing priorities in unit.
• Effective, efficient and tactful oral and written communication skills.
• Ability to solve problems, issues; listen, interpret and confirm understanding of others' communications; and be objective.
• Knowledge of relevant Federal and State regulations, and policies
• Independence, planning and decision-making abilities to complete assigned duties.

Preferred Qualifications

• Experience in managing clinical trials
• Knowledge of UCSF budgeting and contracting requirements
• Relevant experience
• Experience in clinical research or demonstrated research or training experience that translates into a clinical research setting
• Experience conducting literature reviews and writing scientific papers
• Experience in writing, editing, and reviewing scientific manuscripts

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

006229 RSCH CMPLNC ANL 2

Job Category

Administrative Support, Professional (Non-Clinical)

Bargaining Unit

99 - Policy-Covered (No Bargaining Unit)

Location

Remote / Telecommute, Zuckerberg San Francisco General (ZSFG)

Additional Shift Details

Days, Nights, Weekends, Monday - Friday, 8:00 am - 4:30 pm; occasional weekends, nights, and travel