Sr. Clinical Research Coordinator - Breast Oncology

UCSF Health, AG; San Francisco (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

UCSF Health, AG seeks a Senior Clinical Research Coordinator for the Breast Oncology program. The role independently coordinates and oversees one or more clinical studies, providing leadership to junior coordinators and support staff while ensuring regulatory compliance and study integrity.

Reporting to a PI or Director, the incumbent manages CHR approvals, contract generation, subject recruitment, and multicenter trials, including IITs with subsites.

Qualifications

• BS/BA degree or equivalent experience/training.
• Significant project and clinical trial management experience including regulatory/compliance responsibilities.
• In-depth knowledge of clinical research contracts, grants, FDA regulations, and complex visit structures.
• Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of hire.
• Experience with database software such as MS Access or FileMaker Pro.
• Proven ability to develop recruitment strategies in complex environments and diverse patient pools.
• Project management skills to oversee administrative operations of the clinical trials program.
• Excellent interpersonal, verbal and written communication skills.
• Ability to interpret and apply policies and regulations.
• Financial analysis skills and experience with budgets.

Responsibilities

• Coordinate and oversee one or more clinical studies, including NIH/industry trials and IITs.
• Provide leadership to junior coordinators and support staff.
• Ensure CHR approvals, contracts, recruitment, testing, and enrollment meet timelines.
• Collaborate with clinicians, investigators, sponsors, and regulatory bodies to maintain program excellence.
• Develop and implement quality improvement processes for safety, compliance, and efficiency.

Skills

Project management

Regulatory compliance

Communication skills

Analytical skills

Leadership

Education

BS/BA degree

Tools

MS Access

FileMaker Pro

Job description

Senior Clinical Research Coordinators with the Breast Oncology program independently coordinate and are accountable for the overall administration of one or more clinical studies, typically requiring advanced-level knowledge and skills. They may provide leadership to lower-level clinical research coordinators and/or other support personnel.

This Senior Clinical Research Coordinator will support the Breast Oncology program in study activation, study amendment submissions, and the activation and oversight of investigator initiated trials (IITs) with subsites.

The position is responsible for, and critically important to the overall operational management of clinical research activities. It has direct responsibility for implementing a diverse portfolio of research activities for one or more studies which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities, such as a clinical database and biorepository. Positions at this level may perform expert and efficient integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base, substantial leadership skills, effectively working with a variety of people and organizations at UCSF (clinicians, investigators, clinical staff, administration, Committee on Human Research, human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs.

Reporting to a Principal Investigator (PI) or Director, the incumbent may have central responsibility for ensuring CHR approval and compliance, contract generation, negotiation and approval, subject recruitment, appropriate study testing, and adequate enrollment of multicenter clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts; exercise strong administration and management leadership of clinical research, strong research coordination, and may lead experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial oversight, and contractual expertise in negotiations and execution, as well as create and implement quality improvement processes. This is a position of leadership whose main purpose is to ensure that clinical research commitments are met and that the programs maintain a reputation for excellence in all activities.

Department overview

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.

Qualifications

Required Qualifications

• BS/BA degree in a related area; or equivalent experience/training
• Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities
• In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures
• 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
• Experience using database software, such as MS Access or FileMaker Pro
• Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals
• In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures
• Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects
• Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and written communication skills
• Ability to analyze complex and non-routine issues requiring innovative solutions
• Ability to operate effectively in a changing organizational and technological environment
• Ability to assess and respond to audit risk; ability to develop project plans/schedules and motivate team to meet deadlines
• Ability to interpret and apply policies and regulations
• Financial analysis skills; demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgets

Preferred Qualifications

• Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated skills in audit preparation, execution, and follow-up
• Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies
• Experience with grant application procedures, personnel documentation, contract generation and subcontracting, preferably at UCSF
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals

License/Certifications

• 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