Work Schedule Standard Office Hours (40/wk) Environmental Conditions Able to lift 40 lbs. without assistance, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description:
Join us as Clinical Research Coordinator - And manage the day-to-day operations of our clinical trials. Conduct multiple ongoing clinical trials, of varying size and complexity, involving patients or healthy volunteers/subjects. •Complete all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the studyprocess. Interact with the research site team and other interdepartmental staff. •Engage in the entire site operations process, which includes recruitment, enrollment and retention of study participants.•Provide training and guidance to junior team members. Acts as a lead coordinator for certain studies, taking the overall responsibility thereof at the site, liaising with monitors and other stakeholders. Bachelor's degree or equivalent and relevant formal academic / vocational qualification •In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Directly supervises individual contributors, administrative support and / or entry-level professionals. •Understanding of budgets, project planning and performance metrics•Strong English and grammar skills, second language a plus•Sound knowledge of taxonomies (e.g. folder structures, metadata, user access) and/or Records Management principles including but not limited to: FDA Good Clinical Practices; ICH Guidelines and PPDs Standard Operating Procedures and Working Practice Documents; Legal Holds; supporting software and/or PPD's eTMF process and the DIA eTMF Reference Model•Sound knowledge of organization's archival processes and systems (hardware, software, applications, operating systems, basic programming languages, etc.)•Ability to manage the day-to-day operation of Records Management file rooms including but not limited to document control, security and audit preparedness Work is performed in an office environment with exposure to electrical office equipment.•Frequently drives to site locations and frequently travels both domestic and international. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.•Ability to access and use a variety of computer software developed both in-house and off-the-shelf. • When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. Apply today to help us deliver tomorrow's breakthrough.