Job expirat
Our client is a European drug development organization which offers a complete range of clinical development and consulting services to the Pharmaceutical and Biotech industries. On their behalf, we are now welcoming applications from motivated and dynamic professionals for the Clinical Research Associate vacancy.
The main purpose of this position is to manage clinical trials (including study startup, monitoring and closeout) according to the Standard Operating Procedures and Good Clinical Practice guidelines.
The responsibilities of the future employee will include:
• Taking all necessary steps for the set-up and launch of the research project, including feasibility study and relationship with authorities
• Ensuring compliance with the clinical trial protocol of all procedures followed by the study staff (eg. hospital doctors, nurses)
• Ensuring the integrity, accuracy and authenticity of the data submitted through all data collection tools
• Taking corrective measures whenever data incongruence are discovered
• Reporting on Serious Adverse Events, if such events occur
• Assisting with training and development the new employees (less experienced CRAs)
• Liaising with vendors and partners
• Monitoring the expenditure of the resources.
The ideal candidate should possess:
• University Degree (B. Sc.) in Life Sciences or a health-related profession
• Minimum of two years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
• Ability to monitor study sites independently, according to protocol monitoring guidelines, S.O.P.s and GCP
• A full understanding of the Serious Adverse Event reporting
• Ability to work with minimal supervision
• Good analytical, negotiation and communication skills
• Fluency in English, both written and verbal
• Computer skills
• Availability for traveling across the country, up to 80% of the time (including overnight stays)
• Valid driving license.
A competitive package is offered, along with professional development opportunities and exposure to an international environment.
HR Business Consulting este o agentie care aduce un suflu nou pe piata serviciilor de consultanta pe probleme de resurse umane, avand o abordare moderna, apropiata si adaptata clientului, astfel incat cererea si oferta de munca sa se intalneasca cu maximul de succes.