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 follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
• Protect subjects' rights and well-being and ensure data reliability
• 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 product through physical inventory and records review
• Document observations in reports and letters and escalate deficiencies and issues through resolution
• Maintain contact with investigative sites between monitoring visits
• Conduct monitoring tasks according to the approved monitoring plan
• Participate in investigator payment processes and share responsibility for issue and finding resolution
• Provide trial status tracking and progress updates to the Clinical Team Manager
• Update study systems, including the Clinical Trial Management System, and perform required quality-control checks
• Participate in investigator meetings and identify potential investigators with the client company
• Initiate clinical trial sites and ensure trial closeout and retrieval of trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Assist with project publications and tools and perform additional study tasks assigned by the CTM
• 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 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, 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 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 sponsor/client/site requirements, including possible disclosure of vaccination status or other personal information
• Frequent travel generally 60–80%, including frequent drives to site locations and possible extended overnight stays
• Ability to work in office, laboratory, clinical and/or home office environments
• Ability to use required personal protective equipment and work with potential exposure to biological fluids and infectious organisms

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Exposure to global clinical trials and collaboration with international teams