Clinical Research Associate – Level I or II

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage clinical trial procedures, guidelines, documentation and audit readiness
• Monitor investigator sites using risk-based monitoring, root cause analysis and corrective/preventive actions
• Ensure data accuracy through source data review, source data verification and CRF review
• Assess investigational product inventory and records
• Document observations and escalate deficiencies through resolution
• Maintain contact with investigative sites between monitoring visits
• Participate in investigator meetings and identify potential investigators
• Initiate clinical trial sites and make recommendations regarding site suitability
• Perform trial close-out and retrieve trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Provide trial status tracking and progress updates to the Clinical Team Manager
• Update clinical study systems according to study conventions
• Facilitate communication between investigative sites, the client company and the project team
• Respond to company, client and regulatory requirements, audits and inspections
• Complete expense reports and timesheets
• Assist with project publications and tools
• Contribute to project initiatives and process improvement

• Bachelor's degree in a life sciences related field, or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification
• Previous experience comparable to 1 year as a clinical research monitor
• Valid driver's license where applicable
• Equivalency of appropriate education, training and/or directly related experience may be considered
• Proven clinical monitoring skills
• Understanding of medical/therapeutic area knowledge and medical terminology
• Working knowledge of ICH GCPs, applicable regulations and procedural documents
• Critical thinking, root cause analysis and problem-solving skills
• Ability to manage Risk Based Monitoring concepts and processes
• Good oral and written communication skills
• Organizational and time management skills
• Effective interpersonal skills and attention to detail
• Ability to work flexibly, adaptably, independently and in a team
• Solid knowledge of Microsoft Office and ability to learn appropriate software
• Fluency in French and good English language and grammar skills
• Good presentation skills
• Ability to travel frequently to site locations

• Frequent travel, generally 60-80% but more for some individuals, including possible extended overnight stays
• Work-from-home office environment option
• Personal protective equipment provided/required for applicable exposures