Clinical Research Associate

• Manage project activities associated with monitoring functions of Phase I through Phase IV clinical research studies and Real World Evidence studies
• Serve as the main CTI contact for assigned study sites
• Conduct pre-study, site initiation, interim monitoring, and close-out visits and complete visit deliverables
• Assist with study start-up, feasibility, pre-study activities, and site selection
• Collect, review, and track essential and regulatory documents
• Complete general and study-specific training
• Participate in investigator, client, and project team meetings
• Create and implement subject enrollment strategies
• Ensure proper storage, dispensation, and accountability of investigational product and trial-related materials
• Provide ongoing site status updates to the Clinical Project Manager
• Conduct remote monitoring according to study-specific monitoring plans
• Track subject status, CRF retrieval/source document review, regulatory documents, and investigational product using systems and reports
• Support project-specific activities as a member of the Project Team
• Support development, translation, customization, and review of study-related documents
• Support regulatory submission documentation and follow-up where applicable
• Provide regular updates to the Sponsor/Client
• Support site contract negotiation, investigator payments, and site payment tracking where applicable
• Manage ISF and TMF for assigned study sites
• Identify site issues, implement corrective actions, or escalate as appropriate
• Liaise with Clinical Data Management for data cleaning activities
• Assist in preparing and coordinating investigator and client meetings

• At least 1 year of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources
• Bachelor's Degree or higher in an allied health field such as nursing, pharmacy, or health / natural science; or RN with Associate's Degree; or 3-year Nursing Diploma with at least 2 years of clinical nursing experience; or equivalent experience as determined by CTI Management and Human Resources
• Previous experience conducting clinical research studies in a hospital setting, pharmaceutical company, or CRO
• Knowledge of the drug development process, ICH/GCP, and relevant regulations
• Ability to perform site management activities in adherence to regulatory guidelines and SOPs

• Structured mentoring program
• Leadership courses
• Tuition reimbursement
• Dedicated training department
• Generous health benefits
• Vacation packages
• Hybrid work from home opportunities
• Paid parental leave
• CTI Cares program
• Work-life balance support