University of California - San Francisco Campus and Health
Clinical Research Coordinator - Clinical Research Network Office
University of California - San Francisco Campus and Health, San Francisco, California, United States, 94199
Overview
Clinical Research Coordinator - Clinical Research Network Office HDF Comprehensive Cancer Center Full Time 86579BR Job Summary
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 is 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 QuantumLeap 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). The CRC will serve as the Berkeley site coordinator for the I-SPY 2 trial, which includes up to eight treatment regimens, two correlative science trials, a registry trial, and a quality of life study. Responsibilities
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; coordinate lab and pathology sample collection (including 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 for submission to sponsors and/or appropriate agencies; collect, enter and clean data into study databases, maintaining data quality. Assist with data analysis and preparation of reports and tables; attend team meetings; perform other duties as assigned. Salary and Benefits
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 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, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html Requirements
Required Qualifications
HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities. Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; 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. Preferred Qualifications
Fluency in the usage of IRB online system, iRIS, 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. 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 platforms such as Access, Stata, SPSS, and Teleform. Understanding of policies for reimbursement, research guidelines, confidentiality and HIPAA regulations; adherence to UCSF mission and policies on patient safety and confidentiality. Experience applying Good Clinical Practice Guidelines and regulations such as HIPAA, the Protection of Human Subjects, CHR regulations for recruitment and consent, Cash Handling Procedures, Environmental Health and Safety Training, and Fire Safety Training. 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. Join us to find a rewarding career contributing to improving healthcare worldwide. 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. 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 Work Style
Fully On-Site Shift
Days Shift Length
8 Hours Additional Shift Details
Monday - Friday
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Clinical Research Coordinator - Clinical Research Network Office HDF Comprehensive Cancer Center Full Time 86579BR Job Summary
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 is 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 QuantumLeap 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). The CRC will serve as the Berkeley site coordinator for the I-SPY 2 trial, which includes up to eight treatment regimens, two correlative science trials, a registry trial, and a quality of life study. Responsibilities
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; coordinate lab and pathology sample collection (including 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 for submission to sponsors and/or appropriate agencies; collect, enter and clean data into study databases, maintaining data quality. Assist with data analysis and preparation of reports and tables; attend team meetings; perform other duties as assigned. Salary and Benefits
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 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, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html Requirements
Required Qualifications
HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities. Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; 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. Preferred Qualifications
Fluency in the usage of IRB online system, iRIS, 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. 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 platforms such as Access, Stata, SPSS, and Teleform. Understanding of policies for reimbursement, research guidelines, confidentiality and HIPAA regulations; adherence to UCSF mission and policies on patient safety and confidentiality. Experience applying Good Clinical Practice Guidelines and regulations such as HIPAA, the Protection of Human Subjects, CHR regulations for recruitment and consent, Cash Handling Procedures, Environmental Health and Safety Training, and Fire Safety Training. 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. Join us to find a rewarding career contributing to improving healthcare worldwide. 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. 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 Work Style
Fully On-Site Shift
Days Shift Length
8 Hours Additional Shift Details
Monday - Friday
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