Clinical Research Associate

1 semana atrás


Porto, Porto, Portugal ICON plc Tempo inteiro

As a Clinical Research Associate (CRA) you will be dedicated to one of our global Healthcare clients who have a strong legacy of innovation and leading the way within a specialist therapeutic area.


Responsibilities:

  • Perform all type of visits from site feasibility to close out visits according to plan, document actions and follow up on action plans
  • Train and guide site staff in safety information handling, systems, protocol and trial procedures to minimize protocol deviations
  • Proactive use of EDC and other data source systems for preparation and conduct on site visits as well as source data verification in collaboration with data management/logistics team
  • Identify potential risks and proactively take action to prevent or mitigate
  • Collaborate with Data Management/logistics in resolving queries
  • Assist to ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan
  • Motivate and build strong relations with site personnel to assist the sponsor in being their preferred clinical research partner
  • Collaborate with and provide oversight of deliverables from vendors locally, if applicable
  • Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)
  • Participate in Investigators Meetings to ensure relations with sites as well as active presentation as applicable
  • Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements
  • Support audits and inspections at sites and affiliate, as applicable
Número de vacantes: 1

Modalidad de trabajo:
Full remoto (100%)

Tipo de contrato:
Indefinido

Ventajas sociales o económicas
Competitive salary and additional social benefits (Health Insurance, Life Insurance, Lunch vouchers)

"

Requisitos

  • Bachelor or Master's degree in life sciences or other relevant fields.
  • At least 12 years of experience as a Clinical Research Associate.
  • Therapeutic area knowledge and demonstrating an understanding of oncology (solid tumors) phase I studies is an advantage.
  • Excellent knowledge of Clinical Trial Management Systems, Good Clinical Practices and Trial Management.
  • Strong analytical and communication skills with business, industry understanding and stakeholder management.
  • Fluent in both Portuguese and English.
  • Valid driver's license.
Estudios mínimos
Licenciado

Idiomas:

Inglés nível Perfecto.

  • Experiência mínima
2 años

Disponibilidad para viajar
El 40% del tiempo laboral

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