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Clinical Research Coordinator I

Thermo Fisher

Clinical Research Coordinator

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 study process. 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.

Vacancy posted more than 2 months ago

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