Clinical Research Associate II / SR. CRA (Level depends on experience)

CTI Clinical Trial and Consulting Services; Região Geográfica Intermediária de São Paulo; Presencial; BRL 100.000 - 150.000; Tempo integral

Resumo da oferta

A CTI Clinical Trial and Consulting Services está buscando um Clinical Research Associate II / SR. CRA para atuar como contato principal em estudos clínicos. O papel envolve monitoramento de ensaios, gerenciamento de documentos regulatórios e definição de estratégias de envolvimento de sujeitos, em um ambiente colaborativo e desafiador. Os candidatos devem ter pelo menos 3 anos de experiência em monitoramento de ensaios clínicos e serem fluentes em inglês.

Serviços

Educação e treinamento continuado

Bônus em dinheiro regularmente

Programa de mentoria

Apoio ao equilíbrio entre vida profissional e pessoal

Qualificações

• Mínimo de 3 anos de experiência em monitoramento de ensaios clínicos.
• Experiência prévia em estudos clínicos em hospitais, empresas farmacêuticas ou CRO.
• Complete inscrição para trabalhar no Brasil.

Responsabilidades

• Servir como contato principal da CTI para locais de estudo designados.
• Realizar visitas de site e completar entregas de visita de site de acordo com os prazos.
• Assistir nas atividades de início de estudo, incluindo seleção de sites.

Conhecimentos

Fluência em inglês

Proficiente em espanhol

Monitoramento de ensaios clínicos

Gerenciamento de documentos regulatórios

Capacidade de trabalhar em equipe

Formação académica

Bacharelado em área da saúde como enfermagem, farmácia ou ciência da saúde

Descrição da oferta de emprego

Clinical Research Associate II / SR. CRA (Level depends on experience)

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Clinical Research Associate II / SR. CRA (Level depends on experience)

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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

www.ctifacts.com

• 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 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 projects(s0
  
  

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 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 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 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?

• We support career progression – We have a structured mentoring program to provide the support you need to move forward
• We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
• We value our people - We have never had a layoff in our 20-year history, support a work-life balance, and have provided cash bonuses every year for the past decade
• Our culture is unparalleled – We've received 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
• We think globally and act locally – We have a global philanthropic program supporting our team’s efforts to improve their local communities (click here to learn more about our “CTI Cares” program)
• We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate (a recent report found that the average turnover for CROs in the US was 30%)
• Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market
  
  

Important Note

In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

• We will never communicate with you via Microsoft Teams or text message
• We will never ask for your bank account information at any point during the recruitment process

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Research Services

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