Lead Site Monitor

1 dia atrás

São Paulo, São Paulo, Brasil beBeeClinicalResearch Tempo inteiro R$900.000 - R$1.200.000

Job Overview:

The Senior Clinical Research Associate (Sr. CRA) plays a pivotal role in the execution of clinical studies at assigned sites, collaborating closely with Country Operations Management Teams.

Main Responsibilities:

  • Carry out selection, initiation, interim monitoring and closeout visits, as well as remote data checks, in accordance with study-specific Clinical Monitoring Plans.
  • Drive site performance, proactively identifying and ensuring timely resolution to study-related issues.
  • Train, support and advise Investigators and site staff in study-related matters, including Risk-Based Quality Management principles.
  • Develop site recruitment strategies and manage enrollment to ensure timely achievement of milestones.
  • Ensure agreed monitoring Key Performance Indicators (KPIs) are observed and remain within accepted quality ranges.
  • Prepare and finalize monitoring visit reports in Clinical Trial Management Systems (CTMS) and provide timely feedback to Principal Investigators.
  • Ensure timely collection and uploading of essential documents into electronic Trial Master Files (eTMF), adhering to ICH-GCP and local requirements.
  • Contribute to the nomination and selection of potential investigators and assist with feasibility assessments.
  • Collaborate with Medical Affairs and other internal stakeholders as needed.
  • Escalate systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issues via established processes.

Essential Skills and Qualifications:

  • Experience in CRA monitoring.
  • Bachelor's degree in a related field, preferably in life sciences, or equivalent qualification.
  • Excellent knowledge of international guidelines ICH-GCP and basic understanding of GMP/GDP.
  • Good medical knowledge and ability to learn relevant therapeutic areas.
  • Good understanding of the drug development process.
  • Excellent written and verbal communication skills.
  • Excellent collaboration and interpersonal skills.
  • Valid driving license.

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