Senior CRA I/II - FSP

• 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 during on-site and remote monitoring
• Assess investigational product inventory and records
• Document observations in reports and letters and escalate deficiencies to clinical management
• Follow issues through resolution and maintain contact with investigative sites between monitoring visits
• Conduct monitoring tasks according to the approved monitoring plan
• Participate in investigator payment processes
• Provide trial status tracking and progress updates to the Clinical Team Manager
• Update study systems, including the Clinical Trial Management System, and perform report quality control checks
• Participate in investigator meetings and identify potential investigators
• Initiate clinical trial sites in compliance with protocols, regulations, and ICH GCP obligations
• Ensure trial closeout and retrieval of trial materials
• Ensure essential documents are complete and maintained according to ICH-GCP and applicable regulations
• Conduct on-site file reviews
• Assist with project publications and tools and contribute ideas to the project team
• Perform additional study tasks assigned by the Clinical Team Manager
• Facilitate communication between investigative sites, the client company, and the project team
• Respond to company, client, and regulatory requirements, audits, and inspections
• Complete administrative tasks such as expense reports and timesheets
• Contribute to project work and process improvement initiatives

• Bachelor's degree in a life science related field, or 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 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, attention to detail, and ability to perceive underlying issues
• Effective interpersonal skills
• Strong 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

• Fully remote work arrangement
• Standard Monday–Friday work schedule