Senior Clinical Research Coordinator - Head and Neck Oncology Program

Ucsf Medical Center - San Francisco, CA

Full-time - Mid Level

San Francisco, CA

Hospitals

About the position

The Senior Clinical Research Coordinator (Sr. CRC) for the Head and Neck Oncology Program at the UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) plays a pivotal role in the administration and coordination of clinical studies. This position requires advanced-level knowledge and skills, as the Sr. CRC is responsible for the overall operational management of clinical research activities. The role involves independently coordinating a diverse portfolio of research activities, which may include multicenter clinical trials, local investigator-initiated trials, and programmatic clinical research activities such as clinical databases and biorepositories. The Sr. CRC is expected to integrate multiple complex programmatic activities effectively, applying a sophisticated medical knowledge base and substantial leadership skills while collaborating with various stakeholders, including clinicians, investigators, and regulatory bodies. In this leadership position, the Sr. CRC will ensure compliance with the Committee on Human Research (CHR) regulations, manage contract generation and negotiation, and oversee subject recruitment and study testing. The role demands strong administrative and management leadership to ensure optimal systems for efficiency, compliance, safety, and financial oversight. The Sr. CRC will also be responsible for creating and implementing quality improvement processes to maintain the program's reputation for excellence. This position requires a physical/health screening as part of the hiring process. The UCSF HDFCCC is recognized nationally for its oncology research, and the clinical research program is fast-paced with a broad portfolio of clinical trials. The mission of the program is to provide patients with access to cutting-edge cancer therapies while ensuring compassionate, patient-centered care. The Sr. CRC will play a crucial role in achieving these goals by managing clinical research commitments and leading a team to ensure the highest standards of research integrity and patient safety.

Responsibilities

• Independently coordinate and manage one or more clinical studies.
• Ensure compliance with CHR regulations and manage contract generation and negotiation.
• Oversee subject recruitment and appropriate study testing for clinical trials.
• Implement quality improvement processes to enhance operational efficiency.
• Lead and mentor lower-level clinical research coordinators and support personnel.
• Collaborate with various stakeholders including clinicians, investigators, and regulatory bodies.
• Develop and adjust recruitment strategies to meet clinical trial goals.
• Analyze complex issues and develop innovative solutions to challenges in clinical research.
• Prepare and present financial analyses, including budgets and projections.
• Maintain a comprehensive understanding of clinical research contracts, protocols, and FDA regulations.

Requirements

• High school graduation with sufficient experience and demonstrated skills in clinical research coordination.
• Certification by the Society of Clinical Research Associates or Association of Clinical Research Professionals, or ability to obtain certification within one year of hire.
• In-depth knowledge of clinical research contracts, grants, and protocols.
• Project management skills to oversee clinical trials operations.
• Exceptional analytical skills and excellent interpersonal communication skills.
• Ability to operate effectively in a changing organizational environment.
• Financial analysis skills and experience in preparing financial projections and budgets.
• Significant project and clinical trial management experience, including regulatory responsibilities.
• Experience using database software such as MS Access or FileMaker Pro.

Nice-to-haves

• Fluency in spreadsheet software and ability to develop complex spreadsheets independently.
• Experience in risk management regarding study subjects and sponsors.
• Familiarity with grant application procedures and contract generation.
• Experience with UCSF HDFCCC research processes and oncology project management.
• Experience with Oncore and UCSF's electronic medical record system, Apex.

Benefits

• Comprehensive health insurance coverage
• Dental and vision insurance
• Retirement savings plan (401k)
• Paid holidays and vacation time
• Tuition reimbursement for further education
• Professional development opportunities
• Flexible scheduling options
• Employee wellness programs