Clinical Research Coord I
Competitive
You'll complete your application on the employer's website.
Competitive
You'll complete your application on the employer's website.
Job type
Salary
Competitive
Location
Sector
Posted
18 days ago
Responsibilities
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
Preferred
second language a plus
Benefits
An environment where collaboration and development are part of the everyday experience
Glassdoor
3.5
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
Waltham, Massachusetts, USA
https://www.thermofisher.com
Distribution of Different Job Fields Receiving Sponsorship
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Management and Executive
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Trends of Total Sponsorships
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Qualifications
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
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
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
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
Second language a plus
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 5 years).
1+ year of leadership responsibility.
Required skills
Clinical Trial Coordination, Participant Recruitment, Enrollment, and Retention, Records Management, FDA Good Clinical Practices, ICH Guidelines, Electronic Trial Master File (eTMF) Processes, DIA eTMF Reference Model, Document Control, Metadata and User Access Management, Project Planning and Performance Metrics, Staff Mentoring
Preferred skills
second language a plus
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