Job Description
Posting Title Clinical Research Associate II
Requisition ID 68790BR
Job Category Clinical Research Associate
Locations Czech Republic
Czech Republic - Prague
Shift 1
Job Posting CRA II – Prague, Oncology or Infectious Diseases
Summary:
CRA II position available to work directly through our CoSource division with a large Pharmaceutical company in the cutting edge area of Oncology, specifically immunotherapy. As an experienced CRA you’ll be involved in initiation, routine & close out visits concentrating on sites in Prague, Czech Republic. Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE!
Requirements:
CRA II
- Ability to monitor Clinical study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
- Excellent understanding of Serious Adverse Event reporting
- Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Prague.
USPs of CRA II role:
- Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit’ targets
- Join a stable team of CRAs and benefit from outstanding training and development, both initially and throughout your career
- Join a company where people tend to stay for 6-10 years rather than 1-3!
- Join a genuinely friendly and supportive company where they allow individuals to take ownership of their own performance.
- Oncology/Infectious Diseases Focussed
Duty Highlights:
As a CRA II you will manage all aspects of study site monitoring according to SOPs, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files. Responsibilities include:
- All aspects 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 collaboration 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
Other Information:
This CRA II role is a full time & permanent position employed through Covance.
Benefits: Full CRA benefits including Car/Car Allowance, Life and Disability Insurance, Lunch Allowance
Key words:
CRA II Clinical Research Associate, Oncology, Infectious Diseases, Prague, Czech Republic, Clinical Monitor, Immunotherapy, CRA II, Cancer Clinical trials
Education/Qualifications *
Experience *
EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.