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Senior Clinical Research Associate-Freelance

Remote: 
Full Remote
Contract: 
Freelance
Work from: 
Brazil

Offer summary

Qualifications:

A minimum of 2 years of monitoring experience in oncology trials., Completion of a science-related Bachelor’s degree., Strong knowledge of ICH-GCP guidelines and clinical monitoring processes., Bilingualism in English and Portuguese is required..

Key responsabilities:

  • Performing data verification of source documents.
  • Conducting site visits including pre-study, initiation, monitoring, and termination.
  • Ensuring compliance with FDA, ICH-GCP, and local regulations.
  • Mentoring junior team members as required.

TRIO - Translational Research in Oncology logo
TRIO - Translational Research in Oncology SME http://www.trioncology.org
201 - 500 Employees
See all jobs

Job description

Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today.

TRIO is looking for a Senior Clinical Research Associate to join our Monitoring Resource team. Reporting to the CRA Line Manager, this position will be a remote fill-time freelance position based in Brazil.

Responsibilities:
  • Performing data verification of source documents;
  • Conducting site visits, including pre-study, initiation, monitoring and termination
  • Confirming adherence to all FDA, ICH-GCP, and local regulations
  • Ensuring implementation and compliance with FDA, ICH-GCP guidelines
  • Participating in budget negotiation and follow-up where applicable
  • Assisting with data validation and query resolution
  • Mentoring junior team members as required.
  • Ensuring the completion and collection of regulatory documents;
Qualifications:
  • A minimum of 2 years of monitoring experience in oncology trials
  • Experience monitoring in early-phase trials will be valued
  • Completion of a science-related Bachelor’s degree
  • Excellent knowledge of medical terminology and clinical monitoring process
  • Strong ICH-GCPs knowledge
  • Experience with clinical trial information systems
  • Ability to travel up to 60% on average
  • Bilingualism (English/Portuguese) is required 

Teamwork · Passion · Integrity · Innovation

Required profile

Experience

Spoken language(s):
EnglishPortuguese
Check out the description to know which languages are mandatory.

Hard Skills

Clinical MonitoringData ValidationClinical TrialsRegulatory ComplianceClinical Trial Management SystemsBudget AnalysisData ValidationAdaptive Clinical Trials

Other Skills

  • Innovation
  • Teamwork
  • Personal Integrity
  • Enthusiasm
Are you interested?

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