Clinical Research Associate Ii

About CTI
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations.
We assist clinical research throughout the lifecycle of development, from drug concept to commercialization.
CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.
For more information, visit
About CTI
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations.
We assist clinical research throughout the lifecycle of development, from drug concept to commercialization.
CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.
For more information, visit
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 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 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 Monitoring Plan, etc.
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Participate in the development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.)
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, 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 an anticipate site issues and implement corrective 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
Function in the role of Lead CRA for assigned projects(s0
What You Bring
At least 3 years of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources
Fluent in English
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 Management and Human Resources
Previous experience in conducting clinical research studies in hospital setting, pharmaceutical company or CRO
You need to be fully eligible to work in Brazil - CTI does not provide VISA Sponsorship
The role is meant in a office-based setting in São Paulo
Proficiency in Spanish is considered an asset
Why CTI?
Advance Your Career – We invest in your professional growth.
Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel.
We also encourage ongoing education to help you achieve your professional goals.
Join an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people.
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