CRA I / CRA II, FSP

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage required clinical trial documentation and sponsor/monitoring procedures
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
• Monitor investigator sites using risk-based monitoring, including root cause analysis and corrective/preventive actions
• Ensure data accuracy through source data review, source data verification and CRF review
• Assess investigational product inventory and records
• Document observations in reports and letters and escalate deficiencies through resolution
• Maintain contact with investigative sites between monitoring visits
• Participate in investigator meetings and identify potential investigators
• Initiate clinical trial sites and make compliance recommendations
• 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 clinical trial management systems according to study conventions
• 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 and timesheets
• Assist with project publications/tools and contribute to process-improvement initiatives

• Bachelor's degree in a life sciences-related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
• At least 1 year of experience as a clinical research monitor, or completion of the PPD Drug Development Fellowship
• Valid driver's license where applicable
• CRA experience with CNS/Alzheimer’s disease
• 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 and attention to detail
• Good organizational and time management skills
• Effective 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
• Good presentation skills
• Ability to work in office, laboratory, clinical and/or home office environments
• Ability to travel frequently to site locations

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Frequent travel generally 60–80%, including potential extended overnight stays
• Personal protective equipment provided/required, including protective eyewear, garments and gloves