CRA; Clinical Research Associate

Responsible for project activities associated with monitoring functions of Phase I through Phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP), and relevant regulations. Performs management of study site activities in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).

What You'll Do

• 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 or oversee 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; may include presentations
• Create and implement subject enrollment strategies for assigned 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 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
• Participate in the development of CRFs and other study related documents (subject worksheets,
• Perform translation, customization, and review of Patient Information sheet and Informed Consent,

protocol synopsis and other study applicable documents as per required procedures

• Where applicable, support or oversee 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 and anticipate site issues and implement corrective and preventive actions or elevate as appropriate
• Liaise with Clinical Data Management for data cleaning activities
• Serve as mentor / trainer for CRAs; may include conducting training/assessment visits
  
  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
• Function in the role of Lead CRA for assigned project(s)