Clinical Research Coordinator II

The Clinical Research Office is responsible for reading/understanding/following clinical research protocols, coordinating specimen collections, processing, shipment, storage, and coordinating manufacturing/receipt of treatment (as applicable), treatment, follow-up. They also assist with extracting data from EMR and original source and reporting (via paper or electronic data capture systems), safety reporting, IRB submissions for new studies, amendments, continuing reviews, close outs, and maintaining regulatory binders. Starting up new studies- budgets/contracts, reading/understanding Medical Coverage Analysis, IRB application, ancillary department approvals, regulatory documents, as well as invoicing for the study. As a certified research professional, the Clinical Research Coordinator II handles clinical trial administration for all protocol phases. Serves as a resource for study team members and principal investigators and assists with subject recruitment, data collection, scheduling of study-related activities and follow-up with enrolled subjects. Assists in quality assurance/control of data resulting from studies. Provides cross-coverage for other CRCs within the department.