CRA II

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote or on-site visits to assess protocol and regulatory compliance
• Manage required clinical trial documentation and sponsor-specific procedures
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
• Support subject rights, well-being, data reliability, and audit readiness
• Develop 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 data 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 updates to the Clinical Team Manager
• Update clinical trial systems, including CTMS, and perform report quality-control checks
• Participate in investigator meetings and identify qualified investigative sites
• Initiate clinical trial sites and make compliance recommendations
• Ensure trial closeout and retrieval of trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls
• Facilitate communication between investigative sites, the client company, and the project team
• Respond to company, client, and regulatory requirements, audits, and inspections
• Complete expense reports and timesheets
• Contribute to process-improvement initiatives and other project work

• 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 or comparable experience
• Valid driver's license where applicable
• Equivalency may be considered through a combination of appropriate education, training, and directly related experience
• 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, attention to detail, and ability to identify underlying issues
• Effective interpersonal, organizational, and time management skills
• Flexibility and adaptability
• Ability to work independently and 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 potential disclosure of vaccination status or other personal information
• Ability to travel frequently, generally 60–80%, with frequent drives to site locations and possible extended overnight stays
• Ability to use required personal protective equipment when applicable

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