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Clinical Research Coordinator III - Tucson, United States - University of Arizona
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Description
Screen, interview, and recruit human subjects for the Community Engagement Alliance (CEAL) research project ensuring eligibility requirements are met and patients have a complete understanding of the informed consent process.
Utilize expert written and oral communication skills to provide instruction to student and community volunteers about their roles within the CEAL project.
Maintain regulatory documentation, protocols, safety reports, and progress reports for the CEAL project. Accurately collect and process clinical data from research participants using study protocol.Develop written operating procedures and perform quality control checks to ensure procedures are followed.
Instrumental in the design and development of additional IRB approved clinical trials as needed. Oversee research study participant's completion of study related activities per study protocol.
Is involved with the preparation, review, submission, and maintenance of regulatory activities/submissions, and will ensure accuracy and timeliness to all collaborative parties, including the University of Arizona IRB.
Collect information from external CEAL sites and prepare comprehensive reports for project leaders and committee members.Provide detailed project update presentations for weekly/monthly meetings that are held on-line and in-person.
Enter data into appropriate data management system and perform validation of data to ensure accuracy, quality, and compliance of data collection process, and make process improvement recommendations to Principle Investigator as appropriate.
Analyze complex clinical trial data to write research reports and prepare study materials.Develop and manage databases for studies, which includes setting up database and associated data entry programs and retrieving data from database for the purposes of analyses or data review.
Provide direct human subject care. Collect and maintain data on subjects. Obtain medical histories and perform medical assessments of clinical trial participants.Ensure that adverse event assessments are conducted, and act as primary liaison between the study subject and the physician concerning any problems or adverse reactions.
Knowledge, Skills, and Abilities
Extensive knowledge of principles, theories and concepts of the Clinical Research Coordinator III job functions with a strong background in human subject research.
Knowledge of preparing initial study submissions, amendments and annual reports to regulatory offices such as the IRB.