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 required documentation, sponsor procedures and monitoring environments
• 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 data review, source data verification and CRF review
• Assess investigational product through physical inventory and records review
• Document observations in reports and letters, escalate deficiencies and follow issues through resolution
• Maintain contact with investigative sites between monitoring visits
• Conduct monitoring tasks according to approved monitoring plans
• Participate in investigator payment processes and investigator meetings
• Provide trial-status tracking and progress updates to the Clinical Team Manager
• Update clinical study systems and perform CTMS report quality-control checks
• Identify potential investigators and initiate clinical trial sites
• Ensure trial closeout and retrieval of trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Contribute to project publications, tools, process improvements and other assigned study tasks
• Facilitate communication among investigative sites, client companies and the project team
• Respond to company, client and regulatory requirements, audits and inspections
• Complete expense reports, timesheets and other administrative tasks

• Bachelor's degree in a life sciences related field or Registered Nursing certification or equivalent and 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, including communication 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 or 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, including vaccination-status or other personal-information disclosures when required
• Frequent driving to site locations and willingness to travel 60–80% or more
• Ability to work in office, laboratory, clinical and/or home-office environments, with potential exposure to biological fluids, infectious organisms and fluctuating/extreme temperatures

• Frequent travel generally 60–80%, with extended overnight stays possible
• Home office environment/work arrangement
• Personal protective equipment provided/required, including protective eyewear, garments and gloves