University of California - San Francisco Campus and Health
Senior Clinical Research Coordinator
University of California - San Francisco Campus and Health, San Francisco, California, United States, 94199
Senior Clinical Research Coordinator
HDF Comprehensive Cancer CenterFull Time79363BRJob Summary
The Senior Clinical Research Coordinators (Sr. CRC) with the Clinical Research Network Office independently coordinate and are accountable for the overall administration and conduct of one or more 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 and conduct 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, Institutional Review Board (IRB), human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs.Reporting to the Clinical Research Manager (CRM), the incumbent may assist with completing pre-activation tasks such as feasibility surveys and assessment with the study team, coordinate protocol reviews and submissions to Disease Site Committee and Protocol Review Committee. Ensure timely processing of new protocols through the activation pipeline including Medicare coverage analysis and budget sign-off, informed consent approval and IRB submission, contract execution, and billing setup. A central responsibility for assisting with and ensuring IRB approval and compliance, subject recruitment, appropriate study testing, study coordination, data entry and management, and adequate enrollment of multicenter clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts; exercise strong administration, organizational, multitasking, communication, both written and spoken, management leadership of clinical research and strong research coordination.This is a position of leadership whose main purpose is to ensure that clinical research commitments are met and that the programs maintain a reputation for excellence in all activities.Note:
This position requires a physical/health screening.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 sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities and/or equivalent experience/training.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.Preferred Qualifications
Experience in clinical research or demonstrated research or training experience that translates into a clinical research setting. Prior experience with various computer programs (Microsoft Office; internet-based databases) and using specialized software such as OnCore.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 UCSF.Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.Fluency in the usage of Committee of Human Research Preferred (CHR) online iMEDris system 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.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.Working knowledge of federal, state, and local research regulations and guidelines, and research practice methods in a laboratory or clinical setting.Ability to apply it to the assessment, interpretation, and processing of medical data.Prior analytical and writing skills in a science/research environment.Knowledge of clinical research in oncology.Knowledge and experience in managing oncology clinical trials.License/Certification
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.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.Organization
CampusJob Code and Payroll Title
007889 CLIN RSCH CRD SR NEXJob Category
Research and Scientific, Supervisory / ManagementBargaining Unit
University Professional Technical Employees - Research Support Professionals Unit (UPTE-RX)Employee Class
CareerPercentage
100%Location
Hybrid, San Mateo, CAShift
DaysShift Length
8 HoursAdditional Shift Details
Monday - Friday
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HDF Comprehensive Cancer CenterFull Time79363BRJob Summary
The Senior Clinical Research Coordinators (Sr. CRC) with the Clinical Research Network Office independently coordinate and are accountable for the overall administration and conduct of one or more 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 and conduct 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, Institutional Review Board (IRB), human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs.Reporting to the Clinical Research Manager (CRM), the incumbent may assist with completing pre-activation tasks such as feasibility surveys and assessment with the study team, coordinate protocol reviews and submissions to Disease Site Committee and Protocol Review Committee. Ensure timely processing of new protocols through the activation pipeline including Medicare coverage analysis and budget sign-off, informed consent approval and IRB submission, contract execution, and billing setup. A central responsibility for assisting with and ensuring IRB approval and compliance, subject recruitment, appropriate study testing, study coordination, data entry and management, and adequate enrollment of multicenter clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts; exercise strong administration, organizational, multitasking, communication, both written and spoken, management leadership of clinical research and strong research coordination.This is a position of leadership whose main purpose is to ensure that clinical research commitments are met and that the programs maintain a reputation for excellence in all activities.Note:
This position requires a physical/health screening.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 sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities and/or equivalent experience/training.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.Preferred Qualifications
Experience in clinical research or demonstrated research or training experience that translates into a clinical research setting. Prior experience with various computer programs (Microsoft Office; internet-based databases) and using specialized software such as OnCore.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 UCSF.Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.Fluency in the usage of Committee of Human Research Preferred (CHR) online iMEDris system 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.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.Working knowledge of federal, state, and local research regulations and guidelines, and research practice methods in a laboratory or clinical setting.Ability to apply it to the assessment, interpretation, and processing of medical data.Prior analytical and writing skills in a science/research environment.Knowledge of clinical research in oncology.Knowledge and experience in managing oncology clinical trials.License/Certification
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.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.Organization
CampusJob Code and Payroll Title
007889 CLIN RSCH CRD SR NEXJob Category
Research and Scientific, Supervisory / ManagementBargaining Unit
University Professional Technical Employees - Research Support Professionals Unit (UPTE-RX)Employee Class
CareerPercentage
100%Location
Hybrid, San Mateo, CAShift
DaysShift Length
8 HoursAdditional Shift Details
Monday - Friday
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