Full-Time Clinical Research Associate II (CRA II)
Job Description
COVANCE is probably enhancing your quality of life without you even knowing it. We play an important role in bringing new therapies to market by helping to turn raw compounds into safe, effective, and approved drugs that help people live longer, more productive lives.
Our mission – bringing medical miracles to market sooner – impacts the lives of millions of people all over the world. Our current growth of Clinical Development Services (CDS) in Eastern European countries brings new opportunities not only for clinical roles, but also another business functions.
At the moment, to our office in Budapest, we are looking for: Clinical Research Associate II.
As a CRA II you will be responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits.
Responsibilities:
- Site administrating and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP;
- Recruiting potential investigators, preparing EC submissions, translating study-related documentation, organizing of meetings and other tasks as instructed by supervisor;
- Completing Serious Adverse Event (SAE) reporting, processing production of reports;
- Negotiating study budgets with potential investigators and assisting the Covance legal department with statements of agreements as assigned;
- Assisting with training, mentoring, and development of new employees, e.g. co-monitoring.
Required skills, experience and education:
- University/college degree (life science preferred), or certification in a related allied health
profession - Good knowledge of ICH Guidelines and GCP including a basic understanding of
regulatory requirements - Minimum of two (2) year 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,
SOPs, GCP and ICH Guidelines - Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of
reports, narratives and follow up of SAEs - Good planning, organization and problem solving abilities
- Ability to work with minimal supervision
- Good communication and interpersonal skills
- Good analytical and negotiation skills
- Computer competency
- Fluent in Hungarian and very good knowledge of English, both written and verbal
- Works efficiently and effectively in a matrix environment
In return, we offer you the opportunity to develop your career with an international organization; to pursue further training and to take advantage of our flexible conditions and attractive remuneration package.
How to Apply
Please send your application - CV in English to: agata.pantov@covance.com1831 total views, 0 today