Clinical Trials Assistant

Sunrise, FL 33313

Posted: 04/24/2019 Industry: Biotech Job Number: 236775-20190424064307 Pay Rate: 50000 - 55000
KEY ACCOUNTABILITIES: Maintain study information on a variety of databases, tracking this information and filing as appropriate.Assist Clinical Operations Manager in creating, processing, distributing, and managing the receipt of study-related documents (Protocol, Patient Binders, Newsletters, Regulatory Binders, and initial and updated study documents, etc.)Coordinating and scheduling team meetings and teleconferences, with internal and external participants, and responsible for generation of meeting minutesAssist Clinical team with managing team calendars, travel arrangements, and expense reports Assist in setting up and maintaining project files (both computer and hard copies)Serve as a liaison between Clinical Operations Manager, study centers, regional monitors, and Clinical Research Organization Communicate with Clinical Operations Manager as required for study implementation and problem resolutionAssist Clinical Operations Manager in tracking site monitoring frequency and monitoring report submission Assist in tracking Pre-Study, Initiation, Interim and Close-Out Monitoring Visits Assist in the tracking, communication, and processing of all device ordersAssist in coordination of technical support for implants, and responsible for maintaining calendars and implant schedules Assist in reviewing data and outstanding/resolved queries to determine site payments and informing accounting when payments are to be issuedAssist in the ongoing review of all Adverse and Serious Adverse EventsAssist in the processing and tracking of all Clinical Trial AgreementsAssist in site identification and selectionAssist in setting up new study centers (sending out study start-up material, providing the site with assistance, coordinating IRB submission, etc.)Preparation of correspondence to the sites (mailings, memos/notes to file, etc.)Assist in the planning, coordination, set-up, and implementation of Investigator Meetings

Perform various clerical duties (filing, mailing, faxing, creating site files, etc.)
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