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Clinical Research Coordinator II-Department of Neurosurgery

University of Florida · Gainesville, Florida, US

Classification Title: Clinical Research Coordinator II Classification Minimum Requirements: Bachelor's degree in an appropriate area and two years of relevan...

Job description

Classification Title: Clinical Research Coordinator II Classification Minimum Requirements: Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience. Job Description: Research Coordination Clinical Data Collection and Outcomes Reporting - Coordinate clinical research studies and clinical trials in compliance with Good Clinical Practice (GCP) standards and other regulatory and legal requirements. - Screen and assist with the identification of research participants. - Obtain informed consent from study participants. - Schedule clinic visits and required testing for research participants. - Assist regulatory and research administration teams with preparation and management of IRB submissions. - Document investigational product (drug/device) accountability. - Create and maintain organized research study files and regulatory documentation. - Develop and manage research databases. - Perform accurate data entry and maintain study records. - Self-monitor and self-audit responsibilities. - Assist in the maintenance of ClinicalTrials.gov. - Develop case report forms (CRFs). - Trains junior coordinators and delegat...