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Excelya

Senior CRA, Site Monitor II

Excelya

. Ensure regulatory, ICH-GCP, and protocol compliance .

Posted 9/17/2026full-timeAthens • GreeceSeniorWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical monitoring with a focus on ICH-GCP compliance, site performance evaluation, and effective communication with stakeholders. Proficient in managing site-level activities and ensuring adherence to study plans and regulatory requirements.

Highest-signal resume keywords
Clinical Monitoring ExperienceICH-GCP ComplianceOncology ExpertiseEffective CommunicationProblem-Solving Skills

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Regulatory ComplianceSource Document ReviewProtocol Deviation ManagementAction Plan DevelopmentMonitoring Activities
Soft Skills
AdaptabilityEffective CommunicationProblem-Solving
Tools & Technologies
Tracking Systems
Industry Keywords
Clinical TrialsOncologySOPsAdverse Event MonitoringSite Management

About the role

Key responsibilities & impact
  • Ensure regulatory, ICH-GCP, and protocol compliance
  • Evaluate site and staff performance, recommend site-specific actions, escalate key issues, and develop action plans
  • Maintain current knowledge of ICH-GCP, regulations, and company SOPs/processes
  • Check site and external facilities, equipment, and supplies for adequate trial conduct and expiry dates
  • Conduct source document review and verification of site source documents and medical records
  • Manage reporting and follow-up of protocol deviations
  • Enter observations, status updates, and action items into tracking systems through resolution
  • Follow up on escalated adverse event monitoring report queries
  • Conduct on-site and remote monitoring activities where permitted by country regulations and the monitoring plan
  • Manage site-level activities and communications to meet project objectives, deliverables, budgets, and timelines
  • Work closely with the Site Manager, investigators, institutions, and other team members
  • Ensure sites follow the study plan and remain ready for inspections

Requirements

What you’ll need
  • 3 years of clinical monitoring experience in oncology is required
  • Effective communication with stakeholders
  • Adaptability to new technologies and processes
  • Problem-solving during process/system changes
  • Willingness to travel
  • Bachelor’s degree or Science degree in a related field, or equivalent education/experience
  • Fluency in Greek and English language

Benefits

Comp & perks
  • High-impact projects
  • Opportunities for personal and intellectual growth
  • Inclusive, collaborative professional environment
  • Individual growth opportunities
  • Space for talents to shine
  • Opportunity to contribute to something bigger