Senior Clinical Research Associate

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site investigator site visits
• Assess protocol and regulatory compliance and manage required documentation
• Apply risk-based monitoring, root cause analysis, critical thinking and problem-solving to identify site process failures 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 and escalate deficiencies and issues through resolution
• Maintain contact with investigative sites between monitoring visits
• Conduct monitoring tasks according to the approved monitoring plan
• Participate in investigator payment processes
• Track trial status and provide progress updates to the Clinical Team Manager
• Update and quality-check clinical trial management systems
• Participate in investigator meetings and identify potential investigators
• Initiate clinical trial sites and support trial close-out and retrieval of trial materials
• Ensure essential documents are complete and maintained according to ICH-GCP and applicable regulations
• Conduct on-site file reviews
• Assist with project publications, tools and other study tasks
• Facilitate communication among investigative sites, the client company and the project team
• Respond to company, client and regulatory requirements, audits and inspections
• Complete expense reports, timesheets and other administrative tasks
• 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
• On-site monitoring experience in Rare Diseases and Alzheimer's clinical trials
• Valid driver's license where applicable
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• Effective clinical monitoring skills
• Understanding of 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
• Strong interpersonal, organizational, time management and attention-to-detail skills
• Ability to work independently and as part of a team
• Proficiency in Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills
• Ability to comply with sponsor/client/site requirements
• Ability to use required personal protective equipment and work around biological fluids and infectious organisms

• Fully remote work mode
• Standard Monday–Friday work schedule
• Opportunity to work with a global team
• Frequent travel and extended overnight stays as applicable to the role