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CRA Level I Remote

Role overview

Qualifications

  • Bachelor's degree in a life sciences related field
  • Registered Nursing certification or equivalent
  • Minimal clinical monitoring experience
  • Valid driver's license

Responsibilities

  • Performs and coordinates different aspects of the clinical monitoring and site management process
  • Conducts remote or on-site visits to assess protocol and regulatory compliance
  • Manages required documentation and procedures from different sponsors
  • Ensures audit readiness and develops collaborative relationships with investigational sites

Key facts

Hard skills

Other skills

  • Relationship Building

About the company

Thermo Fisher Scientific logo

Thermo Fisher Scientific

  • Biotech & Genomics
  • 10,001+
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

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Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Performs and coordinates different aspects of the clinical monitoring and site management process.

Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required

documentation. Manages procedures and guidelines from different sponsors and/or monitoring

environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial

is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and

SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops

collaborative relationships with investigational sites.

Qualifications:

Education and Experience:

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and

relevant formal academic / vocational qualification.

Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.

Valid driver's license.

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