Clinical Research Associate II

hace 3 semanas

Madrid, Madrid, España ESP Labcorp Development S.A.U. A tiempo completo

Clinical Research Associate II Job Summary

This Clinical Research Associate II role is an exciting opportunity to work with our team at ESP Labcorp Development S.A.U. as a site lead, overseeing clinical studies and ensuring compliance with regulatory requirements.

Main Responsibilities

  • Lead site management for clinical studies, adhering to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and Sponsor requirements.
  • Conduct site monitoring responsibilities, including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
  • Prepare and implement project plans related to Clinical Monitoring responsibilities.
  • Ensure subject protection by verifying informed consent procedures and protocol requirements.
  • Safeguard data integrity through careful source document review and verification.
  • Confirm site regulatory documents and eTMF/Sponsor Documents are complete and current.
  • Guarantee accurate study Investigational Product inventory and accountability.
  • Ensure adherence to global quality control and CRA performance metrics.
  • Ensure audit readiness at the site level.
  • Act as a Lead CRA as assigned.

General Monitoring Responsibilities

  • Ensure study staff receive proper materials and instructions to safely enter subjects into the study.
  • Verify screening, informed consent procedures, and protocol requirements are adhered to.
  • Monitor data for missing or implausible data.
  • Ensure study data completeness, accuracy, consistency, and compliance.
  • Identify deficiencies, deviations, and discrepancies, and initiate corrective action.
  • Manage resources efficiently, performing required monitoring tasks according to SOPs and established guidelines.
  • Prepare and submit accurate and timely trip reports.
  • Perform eCRF review, source data verification, query generation, and resolution.
  • Assist with clinical research project administration, recruiting investigators, and collecting investigator documentation.
  • Update and maintain Fortrea or study/Sponsor-specific trial management tools/e-Clinical systems.
  • Track IP shipments and supplies, as needed.
  • Track and follow-up on serious adverse events.
  • Work closely with the study team, aligning monitoring to critical study timelines.
  • Prepare and implement study-specific monitoring plans and site Initiation slides.
  • Attend investigators' meetings, project team meetings, and teleconferences, as needed.
  • Present training content for site initiation.
  • Assist with training of new employees.
  • Perform other duties as assigned by management.

Qualifications

  • University or college degree, or certification in a related allied health profession from an accredited institution.
  • Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
  • Thorough knowledge of monitoring procedures.
  • Basic understanding of the clinical trial process.
  • Fluent in English, both written and verbal.

Experience

  • Minimum of 2 years of Clinical Monitoring experience.

About ESP Labcorp Development S.A.U.

Fortrea is a leading company in the clinical trials industry, committed to revolutionizing the development process. We are seeking motivated problem-solvers and creative thinkers to join our team and make a meaningful global impact.

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