CRA II

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage required documentation, procedures and sponsor or monitoring-environment guidelines
• Ensure trials follow approved protocols, ICH-GCP guidelines, regulations and SOPs
• Ensure audit readiness and build collaborative relationships with investigational sites
• Monitor investigator sites using risk-based monitoring, including root cause analysis 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, escalate deficiencies and follow issues through resolution
• Maintain contact with investigative sites between monitoring visits
• Track trial status and provide progress reports to the Clinical Team Manager
• Update clinical study systems and perform required CTMS report quality checks
• Participate in investigator meetings and identify potential investigators
• Initiate clinical trial sites and support trial closeout and retrieval of materials
• Ensure essential documents are complete and conduct on-site file reviews
• Assist with project publications, tools and additional study tasks
• 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
• Contribute to project work and process-improvement initiatives

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
• 2+ years of experience as a clinical research monitor
• Valid driver's license where applicable
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• Effective clinical monitoring skills
• Understanding of medical/therapeutic area knowledge and medical terminology
• Understanding and 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 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 or 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 sponsor/client/site requirements, including possible vaccination-status or personal-information disclosure

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