Senior CRA – FSP

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote or on-site visits to assess protocol and regulatory compliance
• Manage required clinical trial documentation and sponsor-specific procedures and guidelines
• Ensure trials comply with approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
• Ensure subjects’ rights, well-being and data reliability
• Maintain audit readiness and 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
• Prepare monitoring reports and letters; escalate deficiencies and follow 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 issue/finding resolution
• Track trial status and provide progress updates to the Clinical Team Manager
• Update clinical trial systems, including CTMS, and perform report quality-control checks where required
• Participate in investigator meetings
• Identify potential investigators and initiate clinical trial sites
• Ensure trial close-out and retrieval of trial materials
• Ensure essential documents are complete and properly filed
• Conduct on-site file reviews
• Assist with project publications, tools, newsletters, trip report reviews and CRA team calls
• 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 process-improvement initiatives and other project work

• Bachelor's degree in a life sciences related field or a 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
• 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 and attention to detail
• Effective interpersonal skills
• Strong attention to detail
• 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
• Ability to comply with sponsor/client/site requirements, including possible disclosure of vaccination status or other personal information
• 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 use required personal protective equipment when exposed to biological fluids or infectious organisms

• Fully remote work mode
• Standard Monday–Friday work schedule
• Opportunity to work with global clinical research teams and leading pharmaceutical and biotech companies
• Professional involvement in clinical trials across diverse sponsors and monitoring environments
• Collaborative relationships with investigational sites and project teams