United States Job Openings
University of California San Francisco
Clinical Research Coordinator
Berkeley
FULL TIME
November 19, 2024
The Helen Diller Family Comprehensive Cancer Center (HDFCCC) Clinical Research Network Office is seeking a Clinical Research Coordinator (CRC) to support the I-SPY Program at UCSF Cancer Center Berkeley.
UCSF is the lead site for the I-SPY Program; the program involves novel trial designs in the setting of neoadjuvant chemotherapy to accelerate the drug development process. Our goal is to introduce and rapidly test novel targeted strategies for women at high risk for recurrence, at the time of primary cancer diagnosis, rather than waiting until they develop metastatic disease. Neoadjuvant therapy allows visualization of tumor response to treatment, and thus is the ideal platform to identify mechanisms of resistance, develop diagnostic markers, and individualize therapy.
I-SPY 2, a phase 2 adaptive randomization trial process that will test up to 12 new drugs in approximately 800 patients over 5 years. I-SPY 2 is a unique public/private partnership between Quantum Leap Healthcare Collaborative and the National Cancer Institute (NCI), the Food and Drug Administration (FDA), patient advocates and over 40 major cancer research centers across the United States and Canada.
The CRC will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Principal Investigator, Program Director, and Clinical Research Manager (CRM). I-SPY 2 is a large trial consisting of up to eight different treatment regimens, two correlative science trials, a registry trial, and a quality of life study. The incumbent will be the CRC for the Berkeley site.
The CRC will be responsible for the coordination of the I-SPY 2 TRIAL, which will involve the following: prepare protocol applications and informed consent forms for IRB submission, help design flow sheets, data forms and source documents; gather and interpret medical, surgical and laboratory data regarding clinical trial/study subjects; apply understanding of inclusion/exclusion eligibility criteria for protocols; recruit, enroll, register, schedule and retain study subjects; record protocol specific treatments and adverse events and schedule/coordinate lab and pathology sample collection (requesting pathology samples) and shipment of samples; administer questionnaires/surveys in the clinical research center, assist research personnel to keep patients on study schedules; complete study forms to submit to sponsors and/or appropriate agencies; collect, enter and clean data into study databases, maintaining data quality; assist with data analysis; assist with preparation of reports and tables; attend team meetings; and perform other duties as assigned.
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
UCSF is the lead site for the I-SPY Program; the program involves novel trial designs in the setting of neoadjuvant chemotherapy to accelerate the drug development process. Our goal is to introduce and rapidly test novel targeted strategies for women at high risk for recurrence, at the time of primary cancer diagnosis, rather than waiting until they develop metastatic disease. Neoadjuvant therapy allows visualization of tumor response to treatment, and thus is the ideal platform to identify mechanisms of resistance, develop diagnostic markers, and individualize therapy.
I-SPY 2, a phase 2 adaptive randomization trial process that will test up to 12 new drugs in approximately 800 patients over 5 years. I-SPY 2 is a unique public/private partnership between Quantum Leap Healthcare Collaborative and the National Cancer Institute (NCI), the Food and Drug Administration (FDA), patient advocates and over 40 major cancer research centers across the United States and Canada.
The CRC will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Principal Investigator, Program Director, and Clinical Research Manager (CRM). I-SPY 2 is a large trial consisting of up to eight different treatment regimens, two correlative science trials, a registry trial, and a quality of life study. The incumbent will be the CRC for the Berkeley site.
The CRC will be responsible for the coordination of the I-SPY 2 TRIAL, which will involve the following: prepare protocol applications and informed consent forms for IRB submission, help design flow sheets, data forms and source documents; gather and interpret medical, surgical and laboratory data regarding clinical trial/study subjects; apply understanding of inclusion/exclusion eligibility criteria for protocols; recruit, enroll, register, schedule and retain study subjects; record protocol specific treatments and adverse events and schedule/coordinate lab and pathology sample collection (requesting pathology samples) and shipment of samples; administer questionnaires/surveys in the clinical research center, assist research personnel to keep patients on study schedules; complete study forms to submit to sponsors and/or appropriate agencies; collect, enter and clean data into study databases, maintaining data quality; assist with data analysis; assist with preparation of reports and tables; attend team meetings; and perform other duties as assigned.
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
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.
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.
Required Qualifications
- HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
- Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population.
- Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
- Demonstrated knowledge and understanding of research, especially in the areas of biological sciences
- Prior experience with various computer program (Microsoft Office; internet-based databases) and using
- specialized software such as On Core.
- Ability to sit and work at a computer for several hours per day. May need to travel between one or more campuses via UCSF shuttle. Ability to stand for several hours of the day.
- Experience in clinical research or demonstrated research or training experience that translates into a clinical research setting
- Working knowledge of federal, state, and local research Required regulations and guidelines, and research practice methods in a laboratory or clinical setting
- Ability to apply relevant information to the assessment, Required interpretation, and processing of medical data.
- Ability to independently interpret and apply policies, respond to requests, resolve issues, and provide assistance to faculty and staff at all levels in a team- oriented environment
Preferred Qualifications
- Fluency in the usage of IRB online system, i RIS, for submission, renewal, and modification of protocols through this system.
- Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
- Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
- Experience with electronic medical records.
- Knowledge of location specific and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms.
-
Experience applying the following regulations and guidelines:
- Good Clinical Practice Guidelines
- Health Information and Accountability Act (HIPAA)
- The Protection of Human Research Subjects
- CHR regulations for recruitment and consent of research subjects
- Effective Cash Handling Procedures
- Environmental Health and Safety Training
- Fire Safety Training
- Ability to work with a sensitive population of patients (oncology patients)
- Prior analytical and writing skills in a science/research environment
- Knowledge of clinical research in oncology
- Knowledge and experience in managing oncology clinical trials.
- Membership in a clinical research professional society.
- Knowledge of medical terminology, research policies and guidelines, guidelines for packing / shipping infectious substances, database building / analysis, and data management within some of the following: Access, Stata, SASS / SPSS, and Teleform programming platforms
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.
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.
Organization
Campus
Job Code and Payroll Title
009335 CLIN RSCH CRD
Job Category
Research and Scientific
Bargaining Unit
University Professional Technical Employees – Research Support Professionals Unit (UPTE-RX)
Employee Class
Career
Percentage
100%
Location
Berkeley, CA
Campus
Berkeley
Work Style
Fully On-Site
Shift
Days
Shift Length
8 Hours
Additional Shift Details
Mon-Fri; 8 hours/day
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