CRA II

Pharmaceutical Research Associates, Inc; Portugal; Presencial; EUR 30 000 - 45 000; Tempo integral

Resumo da oferta

Uma empresa de pesquisa clínica está em busca de um Clinical Research Associate (CRA) para coordenar o monitoramento e gestão de ensaios clínicos. Os candidatos ideal possuem formação em ciências, experiência com regulações locais e são fluentes em múltiplas línguas. A ICON valoriza a diversidade e oferece uma cultura inclusiva, além de benefícios que promovem o equilíbrio entre trabalho e vida pessoal.

Serviços

Licença anual

Opções de seguro de saúde

Planejamento de aposentadoria

Programa de Assistência Global ao Empregado

Seguro de vida

Benefícios opcionais como vales para creche e descontos em academias

Qualificações

• Experiência em seleção de locais, iniciação, monitoramento rotineiro e visitas de encerramento.
• Fluente em inglês, português e espanhol.
• Conhecimento das diretrizes ICH/GCP.

Responsabilidades

• Monitorar vários sites de ensaio clínico nas fases I, II, III e IV.
• Colaborar com a equipe para desenvolver compromisso com os cronogramas de estudo.
• Atuar como principal representante do patrocinador.

Conhecimentos

Proficiente em terminologia médica

Habilidades de registro

Atenção aos detalhes

Fortes habilidades técnicas com CTMS, eCRF, eTMF

Formação académica

Bacharelado (ou equivalente)

Descrição da oferta de emprego

Overview

As a Clinical Research Associate (CRA), you will coordinate all aspects of clinical monitoring and site management in accordance with regulatory guidelines, local regulations, and standard operating procedures. You will be a decision-maker, solving problems independently or as part of the client and ICON team. Your responsibilities include managing competing priorities, supporting the on-site team, ensuring investigators follow the clinical trial protocol, providing training, and motivating the team to ensure high-quality results.

Responsibilities

What you will be doing:

• Monitor multiple Phase I, II, III & IV clinical trial sites across different therapeutic areas. Assist other CRAs with co-monitoring activities both remotely and on-site.
• Utilize your customer service mindset to focus on delivering value, building loyalty, and fostering trust with investigators and study coordinators. Respect, knowledge, and adherence to ICH/GCP guidelines are key to successful trial conduct.
• Serve as the main sponsor representative, providing key project updates. Collaborate with the team to develop commitment to study timelines and objectives through regular visits with site staff, both in-person and remotely.
• Review source data to CRF/eCRF to ensure patient safety and data integrity.
• Act as the first point of contact for study sites, escalating concerns/issues to relevant departments including Safety, Investigational Medicinal Product, Local Study Managers, and management as appropriate.
• Oversee site adherence to GCP/ICH practices, ensuring quality of study conduct.

Qualifications

You are:

• Bachelor’s Degree (or equivalent)
• Scientific background
• Proficiency with medical terminology
• Working knowledge of local regulations
• Knowledge of ICH/GCP guidelines
• Excellent record-keeping skills and attention to detail
• Experience conducting site selection, initiation, routine monitoring, and close-out visits both remotely and on-site
• Available to monitor in Portugal and Spain
• Fluent in English, Portuguese, and Spanish, both written and oral
• Strong technical skills with CTMS, eCRF, eTMF

What ICON can offer you:

Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options
• Retirement planning
• Global Employee Assistance Programme through TELUS Health
• Life assurance
• Optional benefits like childcare vouchers, bike schemes, gym discounts, travel passes, and health assessments

Visit our careers website for more: https://careers.iconplc.com/benefits

ICON values inclusion and belonging, providing an accessible environment for all candidates. We are committed to equal opportunity employment and welcome applications from all qualified individuals. If you require accommodations during the application process, please let us know.

Interested but unsure if you meet all requirements? We encourage you to apply—your skills might be exactly what we're looking for.