Covance

Clinical Research Associate II - Senior CRA - sponsor dedicated

Company
Covance
Location
Budapest, Hungary
Salary
Competitive
Posted
30 May 2021
Closes
12 Jun 2021
Ref
10024_63697
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

We are currently looking for talented Clinical Research Associate II - Senior CRAto join our client team in Hungary. You would be working within our Flexible Solutions department dedicated to one sponsor/client. We are entering in the cooperation with a new pharmaceutical company in Hungary and this is an exciting time to join us. Don't miss your chance!

Would you like to work for one of the best known big pharma companies? Our sponsor is a global mid sized pharma company with high working standards. Are you passionate about growing in Clinical Field? We are proud to have an excellent team of the best professionals on the market and are looking for people who are ready to show true performance and interest in Clinical Trials. Do you like responsibilities and challenges? As a Clinical Research Associate you will lead all aspects of study site monitoring according to Covance SOP, ICH guidelines and GCP. You will take part in pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.

You will become a part of our team who is always ready to help. We offer a home based position so you will not spend time on unnecessary travels but at the same time we highlight a true live relationship between colleagues. You will have a possibility to devote all your professional skills and knowledge into monitoring investigational sites as we organize our work environment and responsibilities with high standards.

Our sponsor invests heavily in training and crafts modern system of Clinical Trials so if you are passionate about working with a phenomenal team and expand your horizons feel free to reach us.

Responsibilities include:
  • All details of site management as prescribed in the project plans
  • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
  • Negotiation of study budgets with potential investigators and cooperation with Covance legal department with statements of agreements
  • Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
  • Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems
Education/Qualifications:
  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
Experience:
  • Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
  • Excellent understanding of Serious Adverse Event (SAE) reporting
  • Ability to resolve project-related problems and prioritize workload for self and team
  • You have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).

Similar jobs

Similar jobs