Clinical Research Associate II

Novartis Brasil; São Paulo; Presencial; BRL 60.000 - 110.000; Tempo integral

Resumo da oferta

Uma empresa farmacêutica global procura um Clinical Research Associate II com experiência em monitoramento clínico. O papel envolve gestão de sites de estudos, garantindo conformidade com regulamentos e protocolos. O candidato ideal possui formação em ciências e habilidades de colaboração, com capacidade para trabalhar de forma independente. Esta posição oferece a oportunidade de impactar diretamente a execução de estudos clínicos, contribuindo para a qualidade e eficiência do trabalho de pesquisa.

Qualificações

• Experiência em monitoramento de campo.
• Pelo menos 2 anos de experiência na indústria farmacêutica.
• Capacidade de viajar.

Responsabilidades

• Conduzir atividades de monitoramento contínuo de sites (on-site e remoto) e gerenciar sites de estudo.
• Liaison entre a Novartis e os sites para garantir colaboração bem-sucedida.
• Participar das atividades de organização de auditoria e prontidão para inspeções.

Conhecimentos

Monitoramento Clínico

Adaptabilidade à Mudança Rápida

Colaboração

Integridade de Dados

Tomada de Decisões

Habilidades de Comunicação

Gestão de Sites de Forma Independente

Gestão do Tempo e Organização

Formação académica

Graduação em disciplina científica ou de saúde

Descrição da oferta de emprego

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Summary

Site relationship management role to ensure sustainable trial execution at Site. Performs on-site and remote monitoring activities related to initiation, conduct and timely completion of Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs. Proactive site performance management (recruitment & quality) and early identification of real site needs and issues as the single best point of contact (internally & externally) for all sites. (from issue management to risk identification).

Summary

Site relationship management role to ensure sustainable trial execution at Site. Performs on-site and remote monitoring activities related to initiation, conduct and timely completion of Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs. Proactive site performance management (recruitment & quality) and early identification of real site needs and issues as the single best point of contact (internally & externally) for all sites. (from issue management to risk identification).

About The Role

Major accountabilities:

• Conducts continuous site monitoring activities (onsite and remote) and manages assigned study sites, conducting phase I-IV protocols. Implements site management activities to ensure compliance with protocol, ICH/GCP, global and local regulation including Health Authorities, IRB/EC, data privacy requirements, global and local processes as applicable. Documentation according to GDP and Novartis standards.
• Performs Site Initiation Visit and Site Closeout activities per SOPs and applicable regulations.
• Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset.
• Establish a strong partnership and true collaboration with the site, to increase patient density and decrease issues at site.
• Early engagement with site on patient inventory and patient flow in advance of SIV in close collaboration with global and local study team
• Proactively collaborates with the SSO Clinical Project Manager (CPM) and CRA Manager as well as MSL, CRMA and medical advisor to ensure optimal recruitment, site development and data quality.
• Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines.
• Ensures the site Investigator Folder is up to date. Responsible for collecting essential documents from site and accountable to keep sTMF(s) up to date.
  
  

Key Performance Indicators

• Next level of site collaboration measured by patient density at site, achievements of commitments and targets and deliver customer satisfaction results.
• Meets study milestones.
• Ensures the delivery of high-quality data according to agreed timelines with adherence to prevailing legislation, GCP, Ethical Committee and SOP requirements.
• Quality and timeliness of updating the Novartis systems, monitoring reports, and communication efforts as defined by global KPIs and KQIs
  
  

Minimum Requirements

Work Experience:

• Degree in scientific or healthcare discipline
• Field monitoring experience
• Operations Management and Execution.
• At least 2 years pharmaceutical industry experience.
• Collaborating across boundaries.
  
  

Skills

• Clinical Monitoring/Research/Trials.
• Fast change adaptability.
• Collaboration.
• Data Integrity.
• Decision Making Skills.
• Ability to travel.
• Good communication skills
• Ability to manage sites independently
• Time management and organization capabilities
  
  

Languages

• English (Written and Spoken).
  
  

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing

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