FSP Clinical Research Associate I/Clinical Research Associate II

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site investigator site visits to assess protocol and regulatory compliance
• Manage sponsor procedures and guidelines across different monitoring environments
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
• Protect subjects’ rights and well-being and ensure data reliability and audit readiness
• Monitor investigator sites using risk-based monitoring, including root cause analysis and corrective/preventive actions
• Ensure data accuracy through source document review, source data verification, 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
• Participate in investigator payment processes and investigator meetings
• Help identify qualified 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, provide progress updates, and maintain study systems such as CTMS
• Facilitate communication among investigative sites, the client company, and internal project teams
• Respond to company, client, and regulatory audits or inspections
• Complete expense reports and timesheets
• Assist with project publications, tools, process-improvement initiatives, and other project work

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
• Equivalency may be considered through a combination of appropriate education, training and/or directly related experience
• 1–2 years of experience as a Clinical Research Associate / Monitor
• Valid driver's license where applicable
• 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, attention to detail, and ability to perceive underlying issues
• Good 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 and in a team
• Solid knowledge of Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Ability to travel frequently, generally 60–80%, including possible extended 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 and potentially infectious organisms

• 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 exposure conditions