Álláshirdetés Tartalma:
CLINICAL RESEARCH ASSOCIATE
The Role and your Responsibilities:
As a key member of the site management team you will be responsible for all site-related issues and milestones. You will also actively contribute to department goals and overall EU operational effectiveness.
Your tasks will include:
- Conducting site evaluations post-feasibility to determine site suitability
- Performing site initiations
- Building and maintaining solid relationships with investigators and site staff to improve study set-up cycle times
- Developing site logistics and milestone plans
- Developing site visit plans and conducts monitoring visits
- Supporting site with focused patient recruitment strategies
- Coordinating the collection of data and resolution of discrepancies at site
- Coordinating and tracking clinical study and drug supply activities at site
- Providing point of contact for study information exchange and manages site issues
- Ensuring local clinical study compliance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOP)
- Ensuring quality data generation and conducting Source Data Verification (SDV), as required
- Performing site close-out
- Ensuring appropriate safety reporting and management of adverse events and adverse drug reactions
- Sharing study conduct ‘best practice’ to increase site productivity
- Developing action plans to address study related gaps e.g. site failing to achieve recruitment targets
- Preparing sites for audits
- Escalating site-related issues
- Exchanging information on site performance and issues
What is Required?
- BSc in a life science or qualified nurse or relevant experience within a pharmaceutical/biotechnology/CRO organization.
- Minimum 1 year of CRA/monitoring experience in clinical research
- Fluency in Hungarian and English
- Very good time management and organization skills
- Ability to build and maintain strong relationships
- Strong communication skills, both oral and written
- Willingness to work home-based (in Hungary)
What is Offered?
- Strong, stable position in a large, international Biotechnology company
- A dynamic and exciting working environment
- Individualized coaching and development
- Dedicated training and education
- The chance to work home-based
- A competitive remuneration package
Why this Vacancy is right for you?
This is an exciting opportunity to become part of a dynamic and successful international Biotechnology organization. The company is ranked in the top 20 in Hungary and has seen very large growth on the Hungarian market, thus you will have the chance to become an important part of their future growth and success. If you are looking for a new challenge, the chance to expand your CRA experience and you have the enthusiasm and drive to join a young and dynamic company, then is this is the opportunity for you!
Szükséges iskolai végzettség: Egyetem
Fizetés: 250.000 felett
Szükséges szakmai tapasztalat: 1 év
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