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Clinical Research Coordinator - Genomics / Pediatrics Department: Urology Job Type: Full Time Job Code: 79724BR Job Summary Under the supervision of the Clinical Research Manager, Clinical Research Coordinators (CRC) support the clinical trial management of investigator-sponsored, pharmaceutical-sponsored, and/or other types of consortium trials. Responsibilities include communicating with the Clinical Trial manager to ensure aspects of study initiation of protocols are developed after regulatory and budgetary approval, and reporting study progress to the appropriate PI. The CRC will support 2-3 active studies and 1-2 follow-up studies, depending on the complexity of the patients and procedures. Independently, the CRC maintains protocol files, data collection and subject source records, develops project management documents and electronic data forms for each assigned study. The CRC supports the investigator in research study project management to assure compliance with the Code of Federal Regulations and the ICH Guidance on Good Clinical (Research) Practice as well as UCSF Institutional policies and IRB protocols. The CRC also supports the research team with additional duties as assigned (e.g., obtaining archived biospecimens or data for ongoing studies). The Clinical Research Coordinator 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 Clinical Research Supervisor and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies. Key Responsibilities Support the management and coordination of single or multiple clinical research 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 Clinical Research Supervisor and/or PI with oversight of other research staff. Manage Investigator's protocols in the Committee on Human Research online system, as well as renewals and modifications of protocol applications and the implementation of new studies. Participate in the review and writing of protocols to ensure institutional review board approval within University compliance. 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 all regulatory documents; report study progress to investigators. Participate in any internal and external audits or reviews of study protocols; perform other duties as assigned. Department Description The Department of Urology in the School of Medicine educates medical students, residents, and clinical and postdoctoral fellows in urology; conducts basic science, clinical, and epidemiological research, including clinical trials; and provides professional patient care services. The Department conducts its teaching, research, and patient care activities at five major sites: the Parnassus campus, Mission Bay, Zuckerberg San Francisco General (ZSFG), the San Francisco Veterans Administration Medical Center (SFVAMC), and the UCSF Benioff Children's Hospital Oakland. 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. Possess strong skills for multitasking, meeting competing deadlines, prioritizing and supporting PIs for multiple departments. Outstanding communication skills. Ability to learn new tasks quickly and apply good judgement in unexpected situations. Preferred Qualifications 4yrs college graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities. Previous University of California experience. Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system. Knowledge/experience with research regulatory process. Knowledge/experience with in RedCAP database, Oncore. Knowledge/experience in submitting protocol to Institutional Review Board (IRB or CHR). 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 EPIC medical record system or other 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. 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. 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. 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. #J-18808-Ljbffr
