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Senior Clinical Research Coordinator - Breast Oncology Program
HDF Comprehensive Cancer Center Job Summary The Senior Clinical Research Coordinator (Sr. CRC) for UCSF HDFCCC Breast Oncology department independently coordinates and is accountable for the overall administration of several clinical studies, typically requiring advanced-level knowledge and skills. They may provide leadership to lower-level clinical research coordinators and/or other support personnel.
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.
Directly reporting to the Clinical Research Manager (CRM), the incumbent may have central responsibility in assisting the research team for study start-up and study implementation for pharmaceutical sponsored, cooperative group, and principal investigator-initiated studies. The Sr. CRC must exercise strong administration and management leadership of clinical research, strong research coordination, and may assist in leading less experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial oversight, and implement quality improvement processes. The incumbent will also assist the Protocol Project Managers with regulatory approvals, budgeting, and study initiation, as needed and directed by the CRM.
Under the supervision of the CRM, the Sr. CRC position supports the clinical trial management of oncology trials. Responsibilities include communicating with the lead program study coordinator to ensure aspects of study initiation of protocols are developed after regulatory and budgetary approval; and report study progress to the appropriate PI. The Sr. CRC may support studies with and without active patients as deemed appropriate by the CRM. The Sr. CRC may also lead the coordination of
multi-site studies, where UCSF is the lead site. The incumbent supports the investigators in research study project management to assure compliance with the Code of Federal Regulation and the ICH Guidance on Good Clinical Practice as well as UCSF Institutional policies. The incumbent also supports the research team with additional duties as assigned by the CRM.
The position is a resource and teacher to other CRCs, contributes to the Cancer Center mission, manages more complex studies than the CRC, supports the CRM and fills in during absences. The Sr. CRC is knowledgeable about a variety of electronic databases; acts as a mentor and trainer, and assists with quality assurance activities.
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 $41.72 - $67.10 (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 Department Description The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) holds the prestigious designation of "comprehensive" from the National Cancer Institute (NCI). We combine basic science, clinical research, epidemiology, cancer control and patient care throughout UCSF. Required Qualifications
- Bachelor's degree in related area 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.
- 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.
- Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities.
- Experience using database software, such as MS Access or FileMaker Pro.
- Clinical research experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
- Demonstrated leadership qualities and ability to work constructively with others.
- Highly proactive, attentive to detail, well-organized, proven ability to multitask and meet deadlines.
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 the location.
- Experience with UCSF Helen Diller Family Comprehensive Cancer Center research process with the proven ability to both work independently and seek information from appropriate sources when needed in order to maintain human subject safety and data integrity.
- Experience with oncology project management with a proven ability to work with UCSF Medical Center staff of differing professional levels.
- Experience with genitourinary oncology protocols.
- Experience with training others in oncology clinical trials coordination.
- Experience within the Investigational Trials Resource department of the HDFCCC.
- Experience with Oncore and UCSF's electronic medical record system, Apex.
- Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals or to obtain within one year in new position.
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 San Francisco, CA Additional Shift Details Monday - Friday |
University of California - San Francisco
Dec 20, 2024