Clinical Research Associate I-Cardiovascular Surgery

Mount Sinai Health System • US • published 2026-09-22 23:43:00.300454

Description

The Clinical Research Associate I monitors all aspects of clinical research trial(s) Clinical study life\-cycle responsibilities including site management, ongoing maintenance and closure of pre\-clinical, Phase I through Phase IV, and post\-marketing studies. * Prepares and completes critical study documents and performs final editing/proofing prior to publishing (e.g. protocol; synopsis; flowchart; informed consent template; investigator brochure; monitoring guideline; statement of work laboratory, other vendors, and CROs; consultant agreements; investigative device/drug labels; clinical study worksheets; etc.). * Monitors resources/reports to deliver milestones on time and budget. * Collect, reviews and files all clinical study documentation for assigned trial(s) and investigative sites and maintenance of clinical trial master file (CTMF): assures all documentation is maintained in compliance with all applicable guidelines and corresponding SOPs. * Participates, with the CTM, in the preparation and hosting of clinical study team meetings on an established schedule, providing agenda, recording/distributing of minutes and copying of minutes to CTM. * Works with the CTM to prepare ...

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