Clinical Research Associate I

CTI Clinical Trial and Consulting Services

Serve as main CTI contact for assigned study sites

• Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP

• Assist with study start-up activities, including feasibility, pre-study activities and site selection
• Collect, review and track essential/regulatory documents
• Participate in and complete all general and study specific training as required
• Participate in investigator, client and project team meetings
• Assist in developing patient enrollment strategies with Project Team and study sites
• Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials
• Perform site management activities and provide ongoing updates of site status to Clinical Project Manager
• Conduct remote monitoring and complete all the related activities in accordance with study specific Monitoring Plan
• Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP
• Assist with project-specific activities as member of Project Team
• May support in development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.
• May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures
• Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available.
• Provide regular updates to Sponsor/ Client
• Where applicable, support in contract negotiation with study sites, Investigator payments and tracking of site payments
• Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans
• Identify site issues and implement corrective actions or escalate as appropriate
• Liaise with Clinical Data Management for data cleaning activities