Covance

CRA based in the Netherlands / Sponsor dedicated

Company
Covance
Salary
Competitive
Posted
11 Jan 2019
Closes
04 Mar 2019
Ref
GQ27167

Join Covance as a CRA and be dedicated to one of our main client based in Amsterdam. You would be joining the teams of ou Sponsor, an international pharmaceutical company known for being one of the main innovator in drug development (oncology, cardioloy, endocrinology, rare disease...). 

Be part of a dynamic team and join a work environment offering flexibility, career development perspective and energizing purpose! 

Responsibilites: 

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

Prepare accurate and timely trip reports

Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor

Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned

Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

Assist with training, of new employees, e.g. co-monitoring

Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned

Education / Qualifications:

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)

Experience:

Extensive Clinical Monitoring experience within a CRO or pharma environment

Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines

Good planning, organization and problem solving abilities

Ability to work with minimal supervision

Good communication and interpersonal skills

Good analytical and negotiation skills

Fluent in Dutch and in English, both written and verbal

If you are looking to broaden your therapeutic expertise whilst gaining exposure to a Pharmaceutical working environment this is a fantastic opportunity to seize now! 

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

We are looking forward to hearing from you and welcoming you to Covance!