Regulatory Research Coordinator

Position Responsibilities Facilitates the opening of cancer clinical research protocols. Prepares forms and informed consents for submission to MSMC Institutional Review Board. Prepares regulatory packages for the study sponsors. Organizes study initiations at MSMC and MS-Aventura. Coordinates monitoring visits by study sponsors at MSMC and MS-Aventura. Assists clinical staff in answering queries from study sponsors. Creates regulatory and protocol files for cancer studies. Keeps all regulatory binders/files organized and updated. Submits study amendments, revisions, and updates as needed to the IRB.Coordinates the distribution of newly activated protocols and protocol consent changes/updates to appropriate sites. Submits annual reviews for cancer studies to IRB.Reports adverse events to appropriate entities according to IRB and study sponsor guidelines. Assists with preparation for NCI and FDA audits. Sets up and maintain a tracking log of all submitted/approved IRB documents. Performs ad hoc duties for physician participation in NCI studies. Prepares submissions to the FDA for IND status. Assists Coordinator of Quality Assurance and Data Management in preparing protocol version and consent tracking documents. Acts as resource for research staff and physicians with regard to regulatory requirements. Coordinates activities of study sponsors with physicians and clinical research staff as needed. Performs all assigned tasks including clerical duties (answering telephones, typing, ordering supplies) to assist clinical staff, when required. Assists physicians in manuscript preparation, as required.