Thermo Fisher Scientific

Clinical Research Associate (Level II)

Brazil

Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, HealthcareIndustries

Position Overview

  • Location Type: [Not specified]
  • Job Type: Full time
  • Salary: [Not specified]
  • Work Schedule: Standard (Mon-Fri)
  • Environmental Conditions: Office

This role performs and coordinates all aspects of the clinical monitoring and site management process. The Clinical Research Associate conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. They manage procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). This position 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. The role also ensures audit readiness and develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to the role are outlined in the task matrix.

Responsibilities

  • Perform and coordinate all aspects of the clinical monitoring and site management process.
  • Conduct remote or on-site visits to assess protocol and regulatory compliance.
  • Manage required documentation.
  • Manage procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.).
  • Act as a site processes specialist.
  • Ensure trials are conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs.
  • Guarantee subjects' rights, well-being, and data reliability.
  • Ensure audit readiness.
  • Develop collaborative relationships with investigational sites.

Requirements

  • [Not specified]

Application Instructions

  • [Not specified]

Company Information

  • [Not specified]

Skills

Clinical Monitoring
Site Management
Regulatory Compliance
Documentation Management
Protocol Adherence
ICH-GCP Guidelines
SOPs
Audit Readiness
Relationship Building

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.
Sale of anatomical pathology business could create a temporary product gap.
Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.
Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.
They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.
Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.
Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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