Clinical Research Coordinator

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.

What Youll 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:
Bachelors 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 PPDs eTMF process and the DIA eTMF Reference Model
Sound knowledge of organizations 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. Youll 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 tomorrows breakthrough.