FSP Clinical Research Associate I/II

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage required documentation and sponsor/monitoring-environment procedures
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
• Monitor investigator sites using a risk-based monitoring approach
• Perform root cause analysis and implement corrective/preventive actions
• Ensure data accuracy through SDR, SDV and CRF review
• Assess investigational product inventory and records
• Document observations in reports and letters and escalate deficiencies through resolution
• Maintain contact with investigative sites between monitoring visits
• Conduct monitoring tasks according to approved monitoring plans
• Participate in investigator payment processes and investigator meetings
• Identify potential investigators and initiate clinical trial sites
• Perform trial closeout and retrieve trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Track trial status and provide progress updates
• Maintain accurate and current study systems, including Clinical Trial Management Systems
• Facilitate communication among investigative sites, the client company and internal project teams
• Respond to company, client and regulatory requirements, audits and inspections
• Complete expense reports and timesheets
• Assist with project publications/tools and contribute to process improvement initiatives

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
• 1–2 years of experience as a Clinical Research Associate / Monitor
• Valid driver's license where applicable
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• Basic medical/therapeutic area knowledge and understanding of medical terminology
• Working knowledge of ICH GCPs, applicable regulations and procedural documents
• Good oral and written communication skills, including communication with medical personnel
• Good interpersonal skills
• Customer focus, listening skills and attention to detail
• Organizational and time management skills
• Flexibility and adaptability
• Critical thinking, root cause analysis and problem-solving skills
• Ability to manage Risk Based Monitoring concepts and processes
• Ability to work independently or in a team
• Solid knowledge of Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Willingness and ability to travel frequently (generally 60–80%), including possible overnight stays
• Ability to work in office, laboratory, clinical and/or home office environments
• Ability to use required personal protective equipment and work around biological fluids/infectious organisms

• Fully remote work arrangement
• Standard Monday–Friday work schedule