Protocol Project Coordinator

Job Summary

The Helen Diller Family Comprehensive Cancer Center (HDFCCC) is seeking a Protocol Project Coordinator to join the Early Phase Oncology research team.

The Protocol Project Coordinator (PPC) will work in the Early Phase Oncology research program and serve as a point of contact between the study team including faculty and clinical research coordinators (CRC), outside entities such as sponsors, the Clinical Research Support Office (CRSO), and the Office of Clinical Trial Activation (OCTA) which are centralized service units in the HDFCCC / UCSF offering clinical trial management services. The candidate will be accountable for clinical trial study start up, maintenance and close out, and may assist with study operations, including participant management and data entry, as required. This role will be reporting to the Clinical Research Manager (CRM), Principal Investigator (PI), and / or the Associate Director for Clinical Research Programs (AD CRP).

Incumbent's duties may include, but will not be limited to, assisting with the regulatory aspects of multiple clinical research studies (sponsored, cooperative group, and investigator-initiated studies), help ensure compliance with all relevant regulatory agencies; implement and maintain periodic quality control procedures; ensure policies mandated by the HDFCCC, federal government, any outside entity and study team are followed during trial maintenance phase and close-out; coordinate and prepare for sponsor or collaborator visits such as site initiation, audit and monitor visits; interface with departments to assist with obtaining UCSF approval prior to study initiation; maintain relevant regulatory documents; report study progress to investigators and sponsors; update clinical trial management databases, and perform other duties as assigned.

A successful applicant will thrive in a fast-paced environment, take initiative, and resolve problems and provide clarity in ambiguous situations. We are looking for a go-getter with excellent relationship building skills, and a team player who can also work independently.

Duties Include :

• Complete pre-activation tasks such as feasibility surveys and assessment with study team.
• Assist with protocol reviews and submissions to Disease Site Committee and Protocol Review and Monitoring Committee.
• Identify ancillary committee approval with study team required by a protocol and assist with the process for review.
• Assist PI with the development of concept sheets, investigational brochure or package insert for CRSO regulatory protocol editor for investigator-initiated trials.
• Assist with timely processing of new protocols through the activation pipeline including Medicare coverage analysis and budget sign off, informed consent approval and IRB submission, contract execution, and billing set up.
• Ensure policies mandated by the HDFCCC, federal government, any outside entity and study team are followed during trial activation pipeline, maintenance phase and close-out.
• Coordinate and prepare for sponsor or collaborator visits such as site initiation, audit and monitor visits.
• Update clinical trial management databases.
• Assist with study coordination and data collection for multiple studies within the program's portfolio if needed.
• Assist study team to develop contingency action plans.
• Flexibility to adapt to changing circumstances.
• Excellent organizational skills, multitasking and communication both written and spoken.

Note : This position will require a physical / health screening.

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

Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.

The salary range for this position is $34.32 - $55.19 (Hourly Rate).

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

Required Qualifications

Equal Employment Opportunity

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.

Department Description

The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is one of only two cancer centers in the Bay Area to receive the prestigious designation of "comprehensive" from the National Cancer Institute (NCI).

The HDFCCC integrates 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.

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.