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Full-time

Clinical Research Coord I

Competitive

Tucson, AZScience & PharmaceuticalPosted 18d ago

You'll complete your application on the employer's website.

Role overview

Job type

Full-time

Salary

Competitive

Location

Tucson, AZ

Posted

18 days ago

Job description

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

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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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