Clinical Research Coordinator at University of California - San Francisco
Posted in Other 30+ days ago.
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Type: Full Time
Location: San Francisco, California
The Clinical Research Coordinator (CRC) will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Lead Clinical Research Coordinator, Principal Investigator (PI), and/or the Research Personnel Manager for the Investigational Trials Unit. The individual will coordinate the operations and data collection of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.
The CRC 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; coordinate staff work schedules, assist with training of Assistant CRCs, and assist Research Personnel Manager and/or PI with oversight of other research staff; 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; maintain relevant regulatory documents in partnership with the Regulatory department; report study progress to investigators; and participate in any internal and external audits or reviews of study protocols.
HELEN DILLER FAMILY COMPREHENSIVE CANCER CENTER
The Helen Diller Family Comprehensive Cancer Center (HDFCCC) Oncology Investigational Trials Resource (ITR) Research Programs have experienced unprecedented growth, increasing its number of clinical visits, clinical research staff, protocols, and protocol enrollments. Cancer programs annually enroll over 120 patients in clinical trials. In order to sustain this accrual without compromising quality of research, the ITR is seeking a Clinical Research Coordinator for the Thoracic Oncology Program.
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.\\",\\"
Required Qualifications: HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities Demonstrated knowledge and understanding of research
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
Ability to apply information to the assessment, interpretation, and processing of medical data
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 two to three different supervisors
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
May need to travel between one or more campuses via UCSF shuttle
NOTE: FINGERPRINTING AND BACKGROUND CHECK REQUIRED.
Preferred Qualifications: BA/BS degree with a major in science or related
Prior analytical and writing skills in a science/research environment
Fluency in the usage of Committee of Human Research (IRB) 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 with electronic medical records
Prior experience with various computer programs (Microsoft Office; internet-based databases) and using specialized software such as OnCore
Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA 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, SASS/ SPSS, and Teleform programming platforms
Knowledge of clinical research in oncology, preferably thoracic oncology
Demonstrated knowledge and understanding of research in biological sciences
Knowledge and experience in managing oncology clinical trials and experience with Phase I-III trials
Membership in a clinical research professional society
Experience applying the following regulations and guidelines:
Good Clinical Practice Guidelines
Health Information and Accountability Act (HIPAA)
The Protection of Human Research Subjects
IRB regulations for recruitment and consent of research subjects
Effective Cash Handling Procedures
Environmental Health and Safety Training
Fire Safety Training
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.