Shriners Children's
Location
Sacramento, California
Salary
$32 - $49 / HOUR
The CRC2 ensures oversight and compliance of clinical research activities, serving as the primary liaison between participants, investigators, and sponsors. Key duties include recruiting pediatric subjects, safeguarding data, and managing investigational products in accordance with federal regulations.
Requires at least 3 years of clinical research experience, or 5 years of related experience if no bachelor's degree is held. Preferred qualifications include a Bachelor's or Master's degree in science/healthcare and CCRP or CCRC certification.
Maintains a contemporary knowledge of clinical research regulatory requirements. Has a working knowledge of the complex clinical research process, from protocol development to implementation Responsible for tracking all aspects of projects including all study, investigator and Institutional Review Board (IRB) information, patient recruitment activity, and financial management Responsible for oversight and documentation of the delivery, storage, and disposition of investigational products at the site, in accordance with federal and state regulations and sponsor requirements Coordinates the collection, statistical analysis and dissemination of data results throughout a clinical study Contributes in compiling, critically analyzing and preparing study results to share with research team Demonstrates knowledge of ethical standards set forth by the Belmont Report, the Nuremberg Code and the International Conference of Harmonization GCP standards Safeguards all participants involved in a research study supported and approved by Shriners Hospitals for Children. Maintains patient safety and privacy throughout the study Note: This is not an all-inclusive list of this job's responsibilities. The incumbent may be required to perform other related duties and participate in special projects as assigned.
Required 3 or more years of clinical research experience, e.g. experience with site management, study management, IRB's, and federal regulations regarding clinical research compliance. Without a Bachelor's degree, 5 or more years of specific job-related experience in the administration of clinical research. Preferred Bachelor or Master's, science or other healthcare related field CCRP or CCRC certification Experience in the coordination of intergroup or multi-site clinical studies Knowledge of how drugs, devices and biologicals are developed and regulated Previous experience with study management, safety management and handling of investigational product Experience with study and site management, including the financial and personnel aspects
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