University of California , San Francisco
Senior Clinical Research Coordinator - Gastrointestinal Medical Oncology Program
University of California , San Francisco, San Francisco, California, United States, 94199
Overview
Senior Clinical Research Coordinator - Gastrointestinal Medical Oncology Program
at UCSF. The Gastrointestinal Medical Oncology Program is a dynamic and growing multidisciplinary team focused on cancer research. Program members are involved in conducting translational research including studies authored by Program Investigators and collaborative research projects with multiple cancer centers, private companies in biotechnology, philanthropies and pharmaceutical industries. Department Description
The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is a national leader in oncology research. The HDFCCC clinical research program is a fast paced program with a broad portfolio of clinical trials. The mission of the UCSF HDFCCC clinical research program is to provide patients and their families with streamlined access to cutting-edge cancer therapies, in addition to providing compassionate, patient-centered care, our team of clinicians and researchers is dedicated to improving outcomes for all patients. 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 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 Responsibilities
The Senior Clinical Research Analyst will: Review eligibility of patient cases; abstract medical data; manage and conduct data entry and ensure quality of existing data; develop data collection and management processes, and; ensure compliance in data collection and sharing methods. Streamline the Oncore database in order to reduce data collection redundancies and improve quality assurance and quality control methods. Work closely with Program Investigators, the UCSF Cancer Registry, the Pathology and Radiology departments, and other sources to review eligible patient cases, identify missed cases from past years, and add cases to the NET database at regular intervals. Assist in the interpretation of medical data in order to abstract the data for accurate reporting and statistical analysis. Coordinate with internal and external collaborators at other institutions to share NET clinicopathologic data as described in IRB approved protocols. Perform basic statistical analysis and literature reviews as well as work with Investigators to prepare scientific abstracts, manuscripts and presentations related to relevant research projects. Lead clinical research meetings with collaborators to discuss relevant research projects (as needed). Draft new protocols related to tissue banking and patient-reported outcomes and help to manage other regulatory matters related to relevant protocols. Duties may also include, but are not limited to: creating reports of data capturing progress; retrospective data mining and maintenance of an up-to-date database; analysis of comprehensive datasets; assurance of data integrity; other duties as assigned. Required Qualifications
Bachelors degree in related area and sufficient experience and demonstrated skills to successfully perform the assigned duties 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. Coursework in basic statistical analysis required, preferably with emphasis on biostatistics. Experience in clinical research data management with oncology cases. Experience in medical record extraction. Demonstrated ability to interpret medical information, particularly for oncological data. Experience in scientific writing. A scientific writing sample is required. Experience using statistical analysis software (SAS, SPSS, STATA, R). Experience in management of data quality assurance and quality control methods. 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. Ability to relate effectively in person and via telephone and email with physicians, nurses, data managers, as well as medical records and information science departments. Previous experience working with sensitive populations of patients, preferably cancer patients. Ability to sit and work at a computer for up to 8 hours per day. May need to travel between one or more campuses via UCSF shuttle. Ability to stand for several hours of the day. 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
Masters degree in biological sciences, clinical research, public health, epidemiology/biostatistics or related. 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 Advanced training in statistical analysis. Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPAA 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 neuroendocrine malignancies. 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. 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 worlds 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. UCSF is committed to equity and building a 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 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 Details
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) Employee Class: Career Percentage: 100% Location: San Francisco, CA Campus: Mission Bay (SF) Work Style: Fully On-Site Shift: Days Shift Length: 8 Hours Additional Shift Details: Monday - Friday Seniority level
Not Applicable Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Higher Education
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Senior Clinical Research Coordinator - Gastrointestinal Medical Oncology Program
at UCSF. The Gastrointestinal Medical Oncology Program is a dynamic and growing multidisciplinary team focused on cancer research. Program members are involved in conducting translational research including studies authored by Program Investigators and collaborative research projects with multiple cancer centers, private companies in biotechnology, philanthropies and pharmaceutical industries. Department Description
The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is a national leader in oncology research. The HDFCCC clinical research program is a fast paced program with a broad portfolio of clinical trials. The mission of the UCSF HDFCCC clinical research program is to provide patients and their families with streamlined access to cutting-edge cancer therapies, in addition to providing compassionate, patient-centered care, our team of clinicians and researchers is dedicated to improving outcomes for all patients. 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 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 Responsibilities
The Senior Clinical Research Analyst will: Review eligibility of patient cases; abstract medical data; manage and conduct data entry and ensure quality of existing data; develop data collection and management processes, and; ensure compliance in data collection and sharing methods. Streamline the Oncore database in order to reduce data collection redundancies and improve quality assurance and quality control methods. Work closely with Program Investigators, the UCSF Cancer Registry, the Pathology and Radiology departments, and other sources to review eligible patient cases, identify missed cases from past years, and add cases to the NET database at regular intervals. Assist in the interpretation of medical data in order to abstract the data for accurate reporting and statistical analysis. Coordinate with internal and external collaborators at other institutions to share NET clinicopathologic data as described in IRB approved protocols. Perform basic statistical analysis and literature reviews as well as work with Investigators to prepare scientific abstracts, manuscripts and presentations related to relevant research projects. Lead clinical research meetings with collaborators to discuss relevant research projects (as needed). Draft new protocols related to tissue banking and patient-reported outcomes and help to manage other regulatory matters related to relevant protocols. Duties may also include, but are not limited to: creating reports of data capturing progress; retrospective data mining and maintenance of an up-to-date database; analysis of comprehensive datasets; assurance of data integrity; other duties as assigned. Required Qualifications
Bachelors degree in related area and sufficient experience and demonstrated skills to successfully perform the assigned duties 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. Coursework in basic statistical analysis required, preferably with emphasis on biostatistics. Experience in clinical research data management with oncology cases. Experience in medical record extraction. Demonstrated ability to interpret medical information, particularly for oncological data. Experience in scientific writing. A scientific writing sample is required. Experience using statistical analysis software (SAS, SPSS, STATA, R). Experience in management of data quality assurance and quality control methods. 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. Ability to relate effectively in person and via telephone and email with physicians, nurses, data managers, as well as medical records and information science departments. Previous experience working with sensitive populations of patients, preferably cancer patients. Ability to sit and work at a computer for up to 8 hours per day. May need to travel between one or more campuses via UCSF shuttle. Ability to stand for several hours of the day. 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
Masters degree in biological sciences, clinical research, public health, epidemiology/biostatistics or related. 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 Advanced training in statistical analysis. Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPAA 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 neuroendocrine malignancies. 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. 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 worlds 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. UCSF is committed to equity and building a 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 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 Details
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) Employee Class: Career Percentage: 100% Location: San Francisco, CA Campus: Mission Bay (SF) Work Style: Fully On-Site Shift: Days Shift Length: 8 Hours Additional Shift Details: Monday - Friday Seniority level
Not Applicable Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Higher Education
#J-18808-Ljbffr