Clinical Research Associate II
hace 5 horas
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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