University of California - San Francisco Campus and Health
Clinical Research Coordinator - Cancer Immunotherapy Program
University of California - San Francisco Campus and Health, San Francisco, California, United States, 94199
Clinical Research Coordinator - Cancer Immunotherapy Program
HDF Comprehensive Cancer Center
Full Time
Location: San Francisco, CA
Job Summary The Helen Diller Family Comprehensive Cancer Center (HDFCCC) is seeking a Clinical Research Coordinator (CRC) to join the Cancer Immunotherapy Program within the Division of Hematology/Oncology. The Clinical Research Coordinator will perform independently to execute, manage, and coordinate research protocols, as directed by the Clinical Research Manager and/or the Principal Investigator (PI). The incumbent will coordinate the operations and data collection of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies. Incumbent's duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies (sponsored, cooperative group, and investigator-initiated studies), depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; assist with training of Assistant CRCs help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; assist in maintaining relevant regulatory documents in partnership with the Regulatory department; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned.
Required Qualifications
HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
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.
Demonstrated knowledge and understanding of research, especially in the areas of biological sciences.
Exceptional database management experience and prior experience with various computer programs (Microsoft Office; internet-based databases) and using specialized software such as OnCore.
Experience with medical charts and electronic records.
Ability to sit and work at a computer for several hours per day. May need to travel between one or more campuses via UCSF shuttle. Ability to stand for several hours of the day.
Experience in clinical research or demonstrated research or training experience that translates into a clinical research setting.
Familiarity with specimen processing, or demonstrated ability to learn specimen processing in a laboratory environment.
Working knowledge of, or demonstrated ability to learn federal, state, and local research regulations and guidelines, and research practice methods in a laboratory or clinical setting.
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.
Ability to work with a sensitive population of patients (oncology patients).
Ability to work across several different programs, reporting to 2-3 different supervisors.
Preferred Qualifications
Bachelor's degree with a major in science or related.
Fluency in the usage of Committee of Human Research (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.
Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
Experience with electronic medical records.
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 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, SAS/ 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
Prior analytical and writing skills in a science/research environment.
Knowledge of clinical research in oncology.
Knowledge and experience in managing oncology clinical trials and experience with Phase I-III trials.
Membership in a clinical research professional society.
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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Full Time
Location: San Francisco, CA
Job Summary The Helen Diller Family Comprehensive Cancer Center (HDFCCC) is seeking a Clinical Research Coordinator (CRC) to join the Cancer Immunotherapy Program within the Division of Hematology/Oncology. The Clinical Research Coordinator will perform independently to execute, manage, and coordinate research protocols, as directed by the Clinical Research Manager and/or the Principal Investigator (PI). The incumbent will coordinate the operations and data collection of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies. Incumbent's duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies (sponsored, cooperative group, and investigator-initiated studies), depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; assist with training of Assistant CRCs help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; assist in maintaining relevant regulatory documents in partnership with the Regulatory department; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned.
Required Qualifications
HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
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.
Demonstrated knowledge and understanding of research, especially in the areas of biological sciences.
Exceptional database management experience and prior experience with various computer programs (Microsoft Office; internet-based databases) and using specialized software such as OnCore.
Experience with medical charts and electronic records.
Ability to sit and work at a computer for several hours per day. May need to travel between one or more campuses via UCSF shuttle. Ability to stand for several hours of the day.
Experience in clinical research or demonstrated research or training experience that translates into a clinical research setting.
Familiarity with specimen processing, or demonstrated ability to learn specimen processing in a laboratory environment.
Working knowledge of, or demonstrated ability to learn federal, state, and local research regulations and guidelines, and research practice methods in a laboratory or clinical setting.
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.
Ability to work with a sensitive population of patients (oncology patients).
Ability to work across several different programs, reporting to 2-3 different supervisors.
Preferred Qualifications
Bachelor's degree with a major in science or related.
Fluency in the usage of Committee of Human Research (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.
Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
Experience with electronic medical records.
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 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, SAS/ 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
Prior analytical and writing skills in a science/research environment.
Knowledge of clinical research in oncology.
Knowledge and experience in managing oncology clinical trials and experience with Phase I-III trials.
Membership in a clinical research professional society.
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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