Senior CRA – FSP

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage clinical trial documentation, procedures and sponsor/monitoring-environment guidelines
• Ensure trials follow approved protocols, ICH-GCP guidelines, regulations and SOPs
• Ensure audit readiness and develop collaborative relationships with investigational sites
• Monitor investigator sites using risk-based monitoring, including 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 in reports and letters; escalate deficiencies and follow issues through resolution
• Maintain contact with sites between monitoring visits to confirm protocol adherence and timely data recording
• Track trial status and provide progress reports to the Clinical Team Manager
• Update clinical study systems, including CTMS, and perform quality checks where required
• Participate in investigator meetings and identify potential investigators
• Initiate clinical trial sites and support trial close-out and retrieval of materials
• Ensure essential documents are complete and conduct on-site file reviews
• Assist with project publications/tools and perform additional study tasks assigned by the CTM
• Facilitate communication between sites, the client company and the project team
• Respond to company, client and regulatory requirements, 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 relevant formal academic/vocational qualification
• Minimum of 3 years of completed on-site clinical monitoring experience
• Minimum of 2 years of completed experience as the lead Clinical Research Associate (CRA) on Oncology and/or Hematology clinical trials
• 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 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
• Proficiency in Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills
• Ability to comply with specific sponsor/client/site requirements, including disclosure of vaccination status or other personal information when required

• Frequent travel, generally 60-80% but more for some individuals
• Extended overnight stays may be included
• Work performed in an office/laboratory/clinical/home office environment
• Personal protective equipment provided/required, including protective eyewear, garments and gloves