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Clinical Research Associate
1 semana atrás
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
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.
Licenciado
Idiomas:
Inglés nível Perfecto.
- Experiência mínima
Disponibilidad para viajar
El 40% del tiempo laboral
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