CRA - FSP

• Perform and coordinate all aspects of clinical monitoring and site management
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage required clinical trial documentation and sponsor/monitoring-environment procedures
• 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 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 document review, source data verification, and CRF review
• Assess investigational product inventory and records
• Document observations in reports and letters and escalate deficiencies to clinical management
• Maintain contact with investigative sites between monitoring visits and follow issues through resolution
• Conduct monitoring according to approved monitoring plans and participate in investigator payments
• Participate in investigator meetings
• Identify potential investigators and initiate trial sites in collaboration with the client
• Perform trial closeout and retrieve trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Provide trial status tracking and progress updates to the Clinical Team Manager
• Update study systems, including Clinical Trial Management Systems
• Facilitate communication among investigative sites, the client, and the PPD project team
• Respond to company, client, and regulatory requirements, audits, and inspections
• Complete administrative tasks such as expense reports and timesheets
• Assist with project publications/tools and contribute ideas
• Contribute to project work and process-improvement initiatives
• Travel frequently to site locations, generally 60–80%, with possible extended overnight stays

• Bachelor's degree in a life sciences-related field, Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
• Approximately 1 year of experience as a clinical research monitor, or completion of PPD Drug Development Fellowship
• Valid driver's license where applicable
• Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered
• Proven clinical monitoring skills
• Understanding of medical/therapeutic area knowledge and medical terminology
• Working knowledge 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
• Good oral and written communication skills, including communication with medical personnel
• Customer focus, listening skills, attention to detail, and ability to identify underlying customer issues
• Organizational and time management skills
• Interpersonal skills
• Flexibility and adaptability
• Ability to work independently and in a team
• Solid knowledge of Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Presentation skills
• Willingness and ability to travel frequently, generally 60–80%, with possible extended overnight stays
• Ability to work in office, laboratory, clinical, and/or home office environments
• Ability to use required personal protective equipment, including protective eyewear, garments, and gloves
• Ability to work with potential exposure to biological fluids, infectious organisms, and fluctuating/extreme temperatures

• Fully remote work arrangement
• Standard Monday–Friday work schedule