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 procedures across 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
• 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 SDR, SDV and CRF review during on-site and remote monitoring
• Assess investigational product through physical inventory and records review
• Prepare timely 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
• Track trial status and provide progress updates to the Clinical Team Manager
• Update study systems such as CTMS and perform quality-control checks of CTMS reports
• Participate in investigator meetings and identify potential investigators
• Initiate clinical trial sites and make recommendations regarding site acceptability
• Ensure trial closeout and retrieval of trial materials
• Ensure essential documents are complete and available according to ICH-GCP and regulations
• Conduct on-site file reviews
• Assist with project publications, tools and other study tasks
• 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 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
• Experience in infectious disease (pneumonia) and ophthalmology clinical studies preferred
• 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 and in a team
• Proficiency in 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%, including possible extended overnight stays
• Ability to work with potential exposure to biological fluids and infectious organisms
• Ability to use required personal protective equipment

• Fully remote work mode
• Standard Monday–Friday work schedule
• Work performed in an office/laboratory/clinical/home office environment
• Personal protective equipment such as protective eyewear, garments and gloves