Senior CRA – FSP

• Conduct and coordinate clinical monitoring and site management activities
• Perform remote and on-site visits to assess protocol and regulatory compliance
• Manage required clinical trial documentation and sponsor/monitoring-environment procedures
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
• Ensure subject rights, well-being, data reliability, and audit readiness
• Develop 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 inventory and records review
• Document observations in reports and letters and escalate deficiencies to clinical management
• Maintain contact with investigative sites between monitoring visits and follow issues through resolution
• 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 such as the Clinical Trial Management System and perform report quality-control checks
• Participate in investigator meetings
• Identify potential investigators and initiate clinical trial sites
• Ensure trial closeout and retrieval of trial materials
• Ensure essential documents are complete and in place
• Conduct on-site file reviews
• Assist with project publications/tools and other study tasks assigned by the CTM
• Facilitate communication between sites, the client company, and the PPD project team
• Respond to company, client, and regulatory requirements, audits, and inspections
• Complete expense reports, timesheets, and other administrative tasks
• Contribute to project work and 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, 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
• Proficient knowledge of 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 possible disclosure of vaccination status or other personal information
• Ability to travel frequently, generally 60–80%, with frequent drives to site locations and possible overnight stays
• Ability to use personal protective equipment such as protective eyewear, garments, and gloves

• Fully remote work mode
• Standard Monday–Friday work schedule
• Frequent travel opportunities
• Potential extended overnight stays
• Personal protective equipment provided/required for applicable work
• Exposure to office/laboratory/clinical/home-office work environments