University of California - San Francisco
I-SPY Clinical Research Coordinator
University of California - San Francisco, San Francisco, California, United States, 94199
I-SPY Clinical Research Coordinator
SurgeryFull Time80871BRJob SummaryThe I-SPY 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 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.
Continuing to work under the general supervision of the Principal Investigator and Program Director, the incumbent will be the Coordinator for the multi-site I-SPY 2 TRIAL, of which UCSF is the lead site. 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 coordinator 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 assist with collection and shipment of samples; perform tests 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.Department DescriptionThe UCSF Breast Care Center (BCC) is a nationally recognized leader in breast cancer research. A unit within the Division of Surgical Oncology, in the Department of Surgery, the BCC's clinicians are actively engaged in studies to advance all aspects of breast care including prevention, diagnosis, treatment, and improving quality of life. They are also engaged in designing new processes for health care delivery, customized to the needs of individual breast cancer patients. The BCC Research Program employs 45 full-time faculty and staff, as well as associated subcontractors and consultants.Required QualificationsHS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.Therapeutic oncology clinical trial coordinator experience.Experience working with all regulatory aspects of clinical trials (including FDA, NCI, local IRB, and sponsor).In-depth understanding of clinical trials research and investigational therapeutic trials.Must be an experienced, team-oriented individual with strong organizational skills and the ability to meet deadlines and manage multiple trials.Knowledge of Guidelines for Good Clinical Practice (GCP) and guidelines set by the National Institute of Health (NIH) and National Cancer Institute (NCI) in conducting clinical trials.Strong project coordination skills and experience.Strong understanding of the tenets of clinical trial research and investigational drug trials.Demonstrated ability to be self-directed with excellent organizational and analytical skills.Excellent interpersonal, oral and written communication skills and the ability to interface with all levels of staff and leadership.Self-starter with the ability to both work independently and lead cross-functional teams.Able to integrate information from multiple sources in order to anticipate issues, come up with solutions, and resolve the problems.High degree of commitment, flexibility, motivation, and assertiveness.Ability to work effectively in a multi-disciplinary environment.Preferred QualificationsBA or BS in relevant field.1 - 2 years of phase 1/2 therapeutic oncology clinical trial coordinator experience.Experience with electronic data capture systems.Experience with bio-specimen collection and processing.Experience working in breast cancer.UCSF work experience.Knowledge on how to collect trial data while protecting human subject safety in accordance with HIPAA and PHI policy.Knowledge of translational and basic science.About UCSFThe 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.Pride ValuesUCSF 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.Equal Employment OpportunityThe 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.OrganizationCampusJob Code and Payroll Title009335 CLIN RSCH CRDJob CategoryResearch and ScientificBargaining UnitUniversity Professional Technical Employees - Research Support Professionals Unit (UPTE-RX)Employee ClassCareerPercentage100%LocationMission Bay (SF)ShiftDaysShift Length8 HoursAdditional Shift DetailsMonday - Friday, 8:30am - 5:30pm
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SurgeryFull Time80871BRJob SummaryThe I-SPY 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 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.
Continuing to work under the general supervision of the Principal Investigator and Program Director, the incumbent will be the Coordinator for the multi-site I-SPY 2 TRIAL, of which UCSF is the lead site. 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 coordinator 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 assist with collection and shipment of samples; perform tests 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.Department DescriptionThe UCSF Breast Care Center (BCC) is a nationally recognized leader in breast cancer research. A unit within the Division of Surgical Oncology, in the Department of Surgery, the BCC's clinicians are actively engaged in studies to advance all aspects of breast care including prevention, diagnosis, treatment, and improving quality of life. They are also engaged in designing new processes for health care delivery, customized to the needs of individual breast cancer patients. The BCC Research Program employs 45 full-time faculty and staff, as well as associated subcontractors and consultants.Required QualificationsHS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.Therapeutic oncology clinical trial coordinator experience.Experience working with all regulatory aspects of clinical trials (including FDA, NCI, local IRB, and sponsor).In-depth understanding of clinical trials research and investigational therapeutic trials.Must be an experienced, team-oriented individual with strong organizational skills and the ability to meet deadlines and manage multiple trials.Knowledge of Guidelines for Good Clinical Practice (GCP) and guidelines set by the National Institute of Health (NIH) and National Cancer Institute (NCI) in conducting clinical trials.Strong project coordination skills and experience.Strong understanding of the tenets of clinical trial research and investigational drug trials.Demonstrated ability to be self-directed with excellent organizational and analytical skills.Excellent interpersonal, oral and written communication skills and the ability to interface with all levels of staff and leadership.Self-starter with the ability to both work independently and lead cross-functional teams.Able to integrate information from multiple sources in order to anticipate issues, come up with solutions, and resolve the problems.High degree of commitment, flexibility, motivation, and assertiveness.Ability to work effectively in a multi-disciplinary environment.Preferred QualificationsBA or BS in relevant field.1 - 2 years of phase 1/2 therapeutic oncology clinical trial coordinator experience.Experience with electronic data capture systems.Experience with bio-specimen collection and processing.Experience working in breast cancer.UCSF work experience.Knowledge on how to collect trial data while protecting human subject safety in accordance with HIPAA and PHI policy.Knowledge of translational and basic science.About UCSFThe 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.Pride ValuesUCSF 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.Equal Employment OpportunityThe 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.OrganizationCampusJob Code and Payroll Title009335 CLIN RSCH CRDJob CategoryResearch and ScientificBargaining UnitUniversity Professional Technical Employees - Research Support Professionals Unit (UPTE-RX)Employee ClassCareerPercentage100%LocationMission Bay (SF)ShiftDaysShift Length8 HoursAdditional Shift DetailsMonday - Friday, 8:30am - 5:30pm
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