Senior CRA – FSP

• Perform and coordinate all aspects of clinical monitoring and site management
• Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation
• Manage procedures and guidelines from different sponsors and monitoring environments
• Ensure trials comply with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
• Ensure audit readiness and 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 SDR, SDV, and CRF review during on-site and remote monitoring
• Assess investigational products 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 to confirm protocol adherence, issue resolution, and timely data recording
• Conduct monitoring tasks according to the approved monitoring plan
• Participate in the investigator payment process and share responsibility for issue and finding resolution
• Provide trial status tracking and progress updates to the Clinical Team Manager
• Update clinical study systems, including CTMS, and perform required CTMS report quality checks
• Participate in investigator meetings
• Identify potential investigators and initiate clinical trial sites in collaboration with the client company
• 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 contribute ideas to the project team
• Perform additional study tasks assigned by the CTM, such as trip report review, newsletter creation, and leading CRA team calls
• Facilitate communication between investigative sites, the client company, and the PPD project team
• Respond to company, client, and regulatory requirements, audits, and inspections
• Complete expense reports and timesheets
• Contribute to project work and process-improvement initiatives

• 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
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
• Well-developed critical thinking skills, including critical mindset, in-depth investigation for root cause analysis and problem solving
• Ability to manage Risk Based Monitoring concepts and processes
• Effective oral and written communication skills, including communication with medical personnel
• Customer focus, listening skills, attention to detail, and ability to perceive underlying customer issues
• Effective interpersonal skills
• Strong attention to detail
• Effective organizational and time management skills
• Flexibility and adaptability
• Ability to work in a team or independently
• Proficient knowledge of Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills
• Frequent driving to site locations and frequent travel, generally 60–80%
• Ability to comply with specific sponsor/client/site requirements
• Personal protective equipment required, including protective eyewear, garments, and gloves

• Fully remote work mode
• Standard Monday-Friday work schedule