Senior Clinical Research Associate – FSP

• Perform and coordinate clinical monitoring and site-management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage sponsor procedures and guidelines across FSO, FSP, Government, and other monitoring environments
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
• Protect subjects' rights and well-being and ensure data reliability and audit readiness
• Develop collaborative relationships with investigational sites
• Monitor investigator sites using risk-based monitoring, root cause analysis, critical thinking, and problem-solving
• Ensure data accuracy through source data review, source data verification, and CRF review
• Assess investigational products through physical inventory and records review
• Document observations in timely reports and letters; escalate deficiencies and follow issues through resolution
• Maintain contact with sites between monitoring visits to confirm protocol compliance, issue resolution, and timely data recording
• Conduct monitoring tasks according to approved monitoring plans
• Participate in investigator payment processes
• Track trial status and provide progress updates to the Clinical Team Manager
• Update study systems, including CTMS, and perform required quality-control checks of CTMS reports
• Participate in investigator meetings and identify potential qualified investigators with client collaboration
• Initiate clinical trial sites and make compliance recommendations
• 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, share ideas, and perform additional study tasks assigned by the CTM
• Facilitate communication among investigative 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 3 years of completed on-site clinical monitoring experience
• Minimum 2 years of completed experience as lead Clinical Research Associate (CRA) on Oncology and/or Hematology clinical trials
• Effective clinical monitoring skills
• Medical/therapeutic area knowledge and medical terminology
• Understanding and 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, organizational, and time-management skills
• Flexibility and adaptability
• Ability to work independently or in a team
• Proficiency in Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills
• Ability to travel frequently, 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 comply with sponsor, client, and site requirements, including possible vaccination-status or other personal-information disclosures
• Ability to use required personal protective equipment and work with potential exposure to biological fluids and infectious organisms

• Frequent travel generally 60–80%, with travel expenses implied by required expense-report administration
• Full-time employment
• Fully remote work arrangement