Senior Clinical Research Associate – FSP

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage documentation, procedures, and sponsor or monitoring-environment guidelines
• Ensure trials follow approved protocols, ICH-GCP guidelines, regulations, and SOPs
• Monitor investigator sites using a risk-based monitoring approach
• Apply root cause analysis and identify corrective/preventive actions
• Ensure data accuracy through source document review, source data verification, and CRF review
• Assess investigational products through inventory and records review
• Document observations in reports and letters
• Escalate deficiencies and follow issues through resolution
• Maintain contact with investigative sites between monitoring visits
• Conduct monitoring according to approved monitoring plans and participate in investigator payments
• Provide trial-status tracking and progress updates to the Clinical Team Manager
• Update and quality-check study systems, including CTMS
• Participate in investigator meetings and identify/initiate qualified investigative sites
• Support trial closeout and retrieval of trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Assist with project publications, tools, calls, newsletters, and other study tasks
• Facilitate communication between investigative sites, the client, and the project team
• Respond to audits, inspections, and regulatory requirements
• Complete expense reports and timesheets
• Contribute to process-improvement initiatives

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
• 2+ years of experience as a clinical research monitor
• Valid driver's license where applicable
• Equivalent combination of appropriate education, training, and directly related experience may be considered
• Effective clinical monitoring skills
• Medical/therapeutic area knowledge and medical terminology
• Understanding and application of ICH GCPs, applicable regulations, and procedural documents
• Risk-based monitoring concepts and processes
• Root cause analysis and problem-solving skills
• Effective oral and written communication skills
• Ability to communicate with medical personnel
• Customer focus, listening skills, attention to detail, and ability to identify underlying issues
• Interpersonal, organizational, and time management skills
• Flexibility and adaptability
• Ability to work independently or in a team
• Proficiency in Microsoft Office and ability to learn appropriate software
• Excellent Hungarian language and grammar skills
• Good English language and grammar skills
• Good presentation skills
• Ability to lift 40 lbs. without assistance
• Ability to comply with sponsor/client/site requirements, including possible vaccination-status or personal-information disclosure

• Fully remote work mode
• Standard Monday–Friday work schedule
• Remote and on-site work flexibility
• Frequent travel expenses implied by required site travel
• Personal protective equipment provided/required for applicable exposures