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 sponsor procedures, guidelines and monitoring environments
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
• Monitor investigator sites using a risk-based monitoring approach
• Apply root cause analysis and implement 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 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
• Facilitate communication among investigative sites, the client company and the project team
• Respond to company, client and regulatory requirements, audits and inspections
• Complete expense reports and timesheets
• Assist with project publications and tools
• 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
• At least 1 year of experience as a clinical research monitor, or completion of PPD Drug Development Fellowship
• Equivalency combining appropriate education, training and/or directly related experience may be considered
• 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
• Customer focus, listening skills and attention to detail
• Organizational and time management skills
• Ability to work in a team or independently
• Solid knowledge of Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills
• Willingness and ability to travel frequently, generally 60–80%, including potential overnight stays
• Ability to work in office, laboratory, clinical and/or home office environments
• Ability to use required personal protective equipment

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