DescriptionThe 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.
Responsibilities 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 ...