Clinical Research Associate II

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage sponsor-specific procedures and guidelines
• Ensure trials comply with 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 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
• Prepare timely monitoring reports and letters
• Escalate deficiencies and issues and follow them through resolution
• Maintain contact with investigative sites between monitoring visits
• Participate in investigator payment processes and investigator meetings
• Identify potential investigators and initiate clinical trial sites
• Perform trial closeout and retrieve trial materials
• Ensure essential documents are complete and properly maintained
• Conduct on-site file reviews
• Track trial status and provide progress updates to the Clinical Team Manager
• Update clinical study systems, including Clinical Trial Management Systems
• 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
• Assist with project publications and tools and share ideas with team members
• Contribute to project initiatives and process improvements

• Bachelor's degree in a life science related field OR Registered Nursing certification OR equivalent relevant formal academic/vocational qualification
• Approximately 2 years of experience as a clinical research monitor, or comparable experience providing the required knowledge, skills, and abilities
• Valid driver's license
• 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
• Effective interpersonal skills
• Flexibility and adaptability
• Ability to work independently or in a team
• Microsoft Office proficiency and ability to learn appropriate software
• Good English language and grammar skills
• Presentation skills
• Willingness and ability to travel frequently, generally 60–80%, including possible extended overnight stays
• Ability to work in office and/or home office environments
• Ability to use required personal protective equipment, including protective eyewear, garments, and gloves
• In some cases, an equivalency combining appropriate education, training, and/or directly related experience may be accepted

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