Senior CRA – Level I

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote or on-site visits to assess protocol and regulatory compliance
• Manage required documentation and sponsor procedures/guidelines
• Ensure trials follow approved protocols, ICH-GCP guidelines, regulations and SOPs
• Monitor investigator sites using risk-based monitoring, including RCA, SDR, SDV and CRF review
• Assess investigational products through inventory and records review
• Document observations, escalate deficiencies and follow issues through resolution
• Maintain contact with investigative sites between monitoring visits
• Track trial status and provide progress reports to the Clinical Team Manager
• Update and quality-check clinical trial management systems
• Participate in investigator meetings and identify potential investigators
• Initiate and close out clinical trial sites and retrieve trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Support project publications, tools and additional study tasks
• Facilitate communication among sites, client company and project team
• Respond to audits and inspections
• 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 and relevant formal academic/vocational qualification
• 2+ years of experience as a clinical research monitor or comparable experience
• Valid driver's license where applicable
• Equivalent combinations 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
• Critical thinking, root cause analysis and problem-solving skills
• Ability to manage Risk Based Monitoring concepts and processes
• Effective oral and written communication skills
• Effective interpersonal skills and attention to detail
• Organizational and time management skills
• Flexibility and adaptability
• Ability to work independently and in 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, including possible disclosure of vaccination status or other personal information

• Frequent travel, generally 60-80%, with potential extended overnight stays
• Office/clinical/home office working environments
• Personal protective equipment provided/required, including protective eyewear, garments and gloves