University of California, San Francisco
Clinical Research Coordinator - Clinical Research Network Office
University of California, San Francisco, Berkeley, California, United States, 94709
Clinical Research Coordinator - Clinical Research Network Office
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Clinical Research Coordinator - Clinical Research Network Office
role at
University of California, San Francisco .
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, a phase 2 adaptive randomization trial testing up to 12 new drugs in approximately 800 patients over 5 years. The program accelerates drug development by testing novel targeted strategies for women at high risk for recurrence at the time of primary cancer diagnosis.
Responsibilities The CRC will:
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.
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; 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.
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 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
Salary and Benefits Salary range: $34.32 - $55.19 (Hourly Rate). For more information, visit https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html.
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.
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Clinical Research Coordinator - Clinical Research Network Office
role at
University of California, San Francisco .
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, a phase 2 adaptive randomization trial testing up to 12 new drugs in approximately 800 patients over 5 years. The program accelerates drug development by testing novel targeted strategies for women at high risk for recurrence at the time of primary cancer diagnosis.
Responsibilities The CRC will:
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.
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; 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.
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 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
Salary and Benefits Salary range: $34.32 - $55.19 (Hourly Rate). For more information, visit https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html.
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.
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