Job Details

Company: Covance
Location: Istanbul
Reference: 14255
Closing Date: 27 Apr 18
Type: Permanent
Salary (£): Competitive
Benefits:

Job 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. Successful candidates will enjoy the benefits of working for a company that values a WORK/LIFE BALANCE!

Requirements:

CRA II/SCRA – ONCOLOGY 
 

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

Education/Qualifications:

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 Turkey.
• Fluency in English and Turkish

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 across 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 Focussed

Experience:

• Experience on a similar position

Other Information:

• This role is a full time & permanent position employed through Covance.

Key words:
CRA II, GCP, Clinical Research Associate, Oncology, Istanbul, Turkey, Clinical Monitor, Immunotherapy, Cancer Clinical trials