Senior CRA I/II – FSP

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage required clinical trial documentation and sponsor/monitoring procedures
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
• Maintain audit readiness and collaborative relationships with investigational sites
• Monitor investigator sites using a risk-based monitoring approach
• Apply 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 through inventory and records review
• 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
• Track trial status and provide progress updates to the Clinical Team Manager
• Update clinical study systems and perform CTMS report quality-control checks
• Participate in investigator meetings and identify potential investigators
• Initiate clinical trial sites and recommend actions to ensure compliance
• Close out trials and retrieve trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Assist with project publications, tools, trip report reviews, newsletters and CRA team calls
• Facilitate communication between sites, client companies and the project team
• Respond to company, client and regulatory audits and inspections
• Complete expense reports and timesheets
• Contribute to process-improvement initiatives and other assigned project work

• Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
• At least 3 years of experience as a CRA
• At least 2 years of on-site, hands-on oncology/cell therapy experience
• Effective clinical monitoring skills
• Understanding of medical/therapeutic area knowledge and medical terminology
• Understanding and demonstrated 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
• Ability to communicate effectively with medical personnel
• Customer focus, listening skills and attention to detail
• Effective interpersonal, organizational and time management skills
• Flexibility and adaptability
• Ability to work independently and in a team
• Proficient knowledge of 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 potential disclosure of vaccination status or other personal information

• Frequent travel, generally 60-80% but more for some individuals
• Extended overnight stays may be required
• Work-from-home environment available as part of the office/laboratory/clinical/home office environments
• Personal protective equipment provided/required, including protective eyewear, garments and gloves