Clinical Research Associate

Há 5 dias

São Paulo, São Paulo, Brasil Cti Clinical Trial Services, Inc Tempo inteiro
About the Role

Cti Clinical Trial Services, Inc is seeking a highly skilled and experienced Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for conducting site visits, collecting and reviewing essential documents, and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Conduct site visits, including pre-study visits, site initiation visits, interim monitoring visits, and close-out visits
  • Collect, review, and track essential documents, including regulatory documents
  • Ensure compliance with regulatory requirements, SOPs, and ICH GCP
  • Participate in investigator, client, and project team meetings
  • Develop and implement subject enrollment strategies for assigned study sites
  • 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
  • Perform translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis, and other study-applicable documents
  • 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
  • Provide regular updates to Sponsor/Client
  • Support or oversee the 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 escalate as appropriate
  • Liaise with Clinical Data Management for data cleaning activities
  • Serve as mentor/trainer for CRAs; may include conducting training/assessment visits
  • Function in the role of Lead CRA for assigned project(s)
  • Identify and propose process improvements
  • Provide therapeutic area expertise to team members
Requirements
  • 8 years of clinical trial monitoring experience or equivalent experience as determined by Cti Clinical Trial Services, Inc Management and Human Resources
  • Bachelor's Degree or higher in 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 clinical nursing experience, or equivalent experience as determined by Cti Clinical Trial Services, Inc Management and Human Resources
  • Previous experience in conducting clinical research studies in hospital setting, pharmaceutical company, or CRO
About Cti Clinical Trial Services, Inc

Cti Clinical Trial Services, Inc is a leading provider of clinical trial services. We are committed to delivering high-quality services to our clients and are dedicated to making a difference in the lives of patients. We offer a dynamic and supportive work environment, with opportunities for career growth and development.

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