Clinical Research Coordinator
The purpose of this clinical research coordinator (CRC) position is to carry out the needed tasks to support several ongoing and future COVID-19 observational and clinical trials at UCSF Parnassus and Mount Zion. In this position, the CRC is responsible for screening and enrolling subjects, which includes obtaining informed consent, performing data entry, processing biological specimens, and conducting study activities per protocols. Given the nature of the pandemic, the CRC must commit to working flexible hours, which often includes working late nights and weekends to complete patient enrollments into our numerous studies.
Under the supervision of the site principal investigator, the incumbent of this position will screen all patients in the COVID-19 floor units and medical and surgical intensive care units for eligibility for these clinical studies, work closely with study physicians to obtain consent, and implement all study protocols. The CRC will obtain biospecimens, including serial samples of blood, urine, and tracheal aspirates with the assistance of nurses, respiratory therapists, physicians providing clinical care to enrolled study subjects. The incumbent will label, process, and log these specimens according to study protocols. The collection, processing, and storage of biospecimens will require mastery of basic laboratory techniques including but not limited to centrifugation and pipetting while following proper precautions for safe handling human biospecimens and disposal of reagents. The incumbent will perform extensive medical record review on each enrolled subject and data entry for annotation of data fields in a HIPPA compliant web-based platform.
The duties may include, but will not be limited to supporting the management and coordinating the tasks of multiple clinical research studies; oversee data and biospecimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; help 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 compliance; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned.
To accomplish these goals, the CRC will work closely with the PI, key study personnel and collaborating investigators, and other CRCs in the critical care research group. The incumbent of this position will be supervised primarily by Dr. Michael Matthay, the site principal investigator. The CRC will strictly follow the study protocols; participate in meetings, teleconferences and site visits; maintain study logs, forms and files, and enter research data into databases. The incumbent may be asked to sign non-disclosure agreements with industry partners. Other duties as assigned.
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