Senior Clinical Research Coordinator

Job Summary

The Center for Tuberculosis Senior Clinical Research Coordinator will independently coordinate and be accountable for the overall administration, operational management, oversight, and implementation of several tuberculosis-related studies within the scope of a multi-national TB clinical trial and research consortium (SMART4TB), and other research projects overseen by the UCSF Center for Tuberculosis requiring advanced level knowledge and skills in research conduct. The Coordinator will work as an integral member of a dynamic clinical research team with direct responsibility for the oversight of SMART4TB and UCSF Center for Tuberculosis studies spanning clinical trials, observational, epidemiological, and translational research studies in international settings, which will require the Coordinator to work collaboratively with international colleagues, multiple partners, and funders/sponsors to plan, coordinate, and implement studies.

The Coordinator reports to the UCSF SMART4TB principal investigator (PI) and serves as a liaison between the Technical Area Leads, individual SMART4TB study PIs, the Research Program Manager, UCSF, international partners, and study sponsors to support operational activities to ensure all study expectations are met. The Coordinator supports research operations to ensure optimal systems are in place and plans are executed to maintain a high standard of study efficiency, protocol implementation and compliance, safety, quality assurance and financial oversight. This is an outward-facing position whose main purpose is to ensure that clinical research commitments are met and that the programs maintain a reputation for excellence in all activities.

The Coordinator will work closely with the Vietnam National TB Programme-UCSF (VNTP-UCSF) team. The Coordinator will support study planning, respond to site queries, organize translations, and track procurement, invoicing, budget adjustments, and other administrative needs for study coordination of Center for Tuberculosis projects overseen by the VNTP-UCSF team. The Coordinator will support administrative tasks for the internal UCSF team, including tracking status deadlines for grant reports and submissions, work with study PIs, the Research Program Manager, and pre- and post- award analysts on coordinating reports and submissions, calendaring assistance and scheduling for stakeholder meetings, and draft agendas and meeting minutes.

The Coordinator will work across time zones, requiring the Coordinator to be flexible for early morning and late evening calls with international partners in Vietnam, Uganda, Europe, and elsewhere. The Coordinator will create agendas and content for weekly update calls with international partners. The Coordinator will assist international staff with operational activities, including facilitating contact between PIs and study site, supporting data query resolution, audits, and internal and external monitoring. The position entails international travel for initial study implementation and site monitoring visits. Experience in international work and knowledge of global tuberculosis (TB) work is preferred.
The Coordinator will need to possess project management skills and be comfortable with financial and budgetary tracking of multiple streams of funding, compliance, and audit knowledge. The Coordinator will receive training on basic NIH, USAID, or similar funded grants, grant writing and reporting.

The Coordinator will perform independently or with general direction to execute, manage, and coordinate research protocols, as directed by the Research Program Manager and/or PIs; may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.

The Coordinator’s duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies, including clinical, pharmacy, and laboratory operations, depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, and assist the Research Program Manager and/or individual study PIs and/or Technical Area Leads with oversight of other research staff; manage research protocols in the Committee on Human Research online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure Institutional Review Board approval within University compliance; help assure compliance with all relevant regulatory agencies; contract generation, negotiation, and activation; finance (budgeting and procurement); oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; preparation and submission of progress reports to funders and sponsors; participate in any internal and external audits or reviews of study protocols.

Department Description

The Division of Pulmonary and Critical Care Medicine at ZSFG  provides comprehensive medical care for the community,  develops innovative research aimed at elucidating basic mechanisms of disease, and  translates its research activities into both new clinical initiatives and a rich training environment for the next generation of academic physician scientists.

Required Qualifications

• BS/BA degree in a related area and/or equivalent experience/training. Sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.     
• Ability to obtain certification by the Society of Clinical Research  Associates or the Association of Clinical Research Professionals within one year of date of hire.
• Data management, analysis, and data quality skills/background
• Knowledge and experience working in infectious diseases research or project management
• Expert ability to work with dynamic and diverse group of faculty, staff, and students

• Ability to facilitate workshops or trainings related to TB and global health topics
• Strong self-starter, creative in problem solving and innovations, organized
• Basic knowledge and experience on grants and grant writing (for supplements and progress reports)
• Knowledge on budget monitoring and financial management

Preferred Qualifications

• Masters Degree in a related field such as medicine, nursing, global health, public health, and/or epidemiology
• Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system
• Experience with USAID and USAID-funded grants
• Experience with international work
• Experience with and knowledge of global tuberculosis work

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

007889 CLIN RSCH CRD SR NEX

Job Category

Research and Scientific, Supervisory / Management

Bargaining Unit

University Professional Technical Employees – Research Support Professionals Unit (UPTE-RX)

Location

Zuckerberg San Francisco General (ZSFG)

Additional Shift Details

M-F start and end times are flexible (8 Hours days)