Clinical Research Coord I

Job description

Work Schedule First Shift (Days) Environmental Conditions Office Job Description Join us as Clinical Research Coordinator - And manage the day-to-day operations of our clinical trials. What You’ll Do: • 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. Education and Experience: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 5 years). 1+ year of leadership responsibility. 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. Knowledge, Skills and Abilities: • Directly supervises individual contributors, administrative support and / or entry-level professionals. • Fundamental communication and interpersonal skills with the ability to manage, motivate and mentor staff • Strong organization skills with ability to handle multiple tasks simultaneously, meet rigorous timelines and work effectively in stressful situations • 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; retention schedules; 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 Working Conditions and Environment: • 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. Physical Requirements: • Frequently stationary for 6-8 hours per day. • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. • Moderate mobility required. • Occasional crouching, stooping, bending and twisting of upper body and neck. • 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. • Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. • Frequently interacting with others, relates sensitive information to diverse groups both internally & externally. • Ability to apply basic principles to solve conceptual issues. • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. • Regular and consistent attendance. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthrough.