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Clinical Research Associate

2 meses atrás

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

We are seeking a highly experienced and skilled Clinical Research Associate - Principal to join our team at CTI Clinical Trial Services, Inc. As a key member of our team, you will be responsible for ensuring the successful execution of clinical trials across various therapeutic areas.

Key Responsibilities
  1. Site Management: Serve as the primary point of contact for assigned study sites, ensuring seamless communication and collaboration to meet project objectives.
  2. Monitoring and Quality Assurance: Conduct site visits, complete site visit deliverables, and ensure compliance with regulatory requirements, SOPs, and ICH GCP.
  3. Study Start-Up and Feasibility: Assist with or oversee study start-up activities, including feasibility, pre-study activities, and site selection.
  4. Document Management: Collect, review, and track essential and regulatory documents, ensuring accuracy and completeness.
  5. Training and Development: Participate in and complete all general and study-specific training as required, staying up-to-date with industry developments and best practices.
  6. Communication and Collaboration: Participate in investigator, client, and project team meetings, presenting as needed, and ensuring effective communication with all stakeholders.
  7. Subject Enrollment and Management: Create and implement subject enrollment strategies for assigned study sites, ensuring timely and efficient enrollment.
  8. Investigational Product Management: Ensure proper storage, dispensation, and accountability of all Investigational Product (IP) and trial-related materials.
  9. Site Management and Reporting: Perform site management activities, providing ongoing updates of site status to Clinical Project Managers.
  10. Remote Monitoring and Data Management: Conduct remote monitoring, complete related activities, and utilize systems and reports to track subject status, subject case report form (CRF) retrieval/source document review (SDV), regulatory documents, and IP.
  11. Project-Specific Activities: Assist with project-specific activities as a member of the Project Team, contributing to the development of CRFs and other study-related documents.
  12. Document Translation and Customization: Perform translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis, and other study-applicable documents as per required procedures.
  13. Regulatory Affairs Support: 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 on the evaluation process until approval is available.
  14. Contract Negotiation and Management: Support or oversee the contract negotiation with study sites, Investigator payments, and tracking of site payments.
  15. ISF and TMF Management
  16. Process Improvement and Therapeutic Area Expertise: Identify and propose process improvements, providing therapeutic area expertise to team members.
Requirements
  1. Experience: 8 years of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources.
  2. Education: 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.
  3. Previous Experience: Previous experience in conducting clinical research studies in a hospital setting, pharmaceutical company, or CRO.
About CTI

At CTI Clinical Trial Services, Inc., we recognize that our people are what make our company successful. Our work moves medicine forward. We treat our team members with the respect they deserve, and our numbers show it:

  1. Career Progression: We support career progression, promoting from within and having a structured mentoring program and program for recent graduates to provide the support employees need to move forward.
  2. Education and Training: We value education and training, providing tuition assistance, partnering with universities and colleges to create programs in our field, and having a dedicated training department.
  3. Employee Value: We value our people, having never had a layoff in our three-decade history and guaranteeing full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work-from-home schedule, and paid parental leave.
  4. Culture: Our culture is unparalleled, with multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry.
  5. Global Reach and Local Connections: We think globally and act locally, with employees across 60 countries, maintaining culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.
  6. Future Focus: We are looking toward the future, with a consistent double-digit growth rate over the last decade, investing in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs.
  7. Impact: Our work makes a difference, focusing our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market.