Clinical Research Associate II

Ctifacts; São Paulo; Híbrido; BRL 120 000 - 180 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work opportunities

Structured mentoring program

Resumo da oferta

CTI Clinical Trial and Consulting Services, a global CRO, is seeking a Lead CRA to monitor sites, conduct PSV/SIV/IMV/COV visits, and ensure regulatory compliance in Sao Paulo. Office-based role; Spanish is a plus.

The successful candidate will collaborate with cross-functional teams and support site start-up activities from feasibility to initiation. The position requires Brazilian work eligibility, a ≥3-year clinical monitoring background, and a relevant allied health degree.

Qualificações

• 3+ years of clinical trial monitoring experience or equivalent, as determined by CTI Management and HR.

Responsabilidades

• Serve as main CTI contact for assigned study sites.
• Conduct site visits (PSV, SIV, IMV, COV) and deliverables with quality and on time.
• Assist with study start-up activities, including feasibility, pre-study activities and site selection.
• Collect, review and track essential/regulatory documents.
• 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 Investigational Product and materials.

Conhecimentos

Clinical monitoring

Formação académica

Bachelor's degree or higher in allied health

Descrição da oferta de emprego

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 www.ctifacts.com

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.
• 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
• 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. We support your work-life balance with hybrid work opportunities. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
• Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life‑changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.

Qualifications

Skills

Preferred

Leadership Core: Team Culture

Advanced

Leadership Core: Communication

Advanced

Behaviors

Required

Team Player

Works well as a member of a group

Innovative

Consistently introduces new ideas and demonstrates original thinking

Enthusiastic

Shows intense and eager enjoyment and interest

Dedicated

Devoted to a task or purpose with loyalty or integrity

Motivations

Required

Ability to Make an Impact

Inspired to perform well by the ability to contribute to the success of a project or the organization

Flexibility

Inspired to perform well when granted the ability to set your own schedule and goals

Goal Completion

Inspired to perform well by the completion of tasks