Closing Date: 26 Oct 16
Salary (£): Competitive
Home based role, up to 15K Sign-Up Bonus available for limited time only! Apply online or contact me for more details http://careers.covance.com/job-postings/60934BR/clinical-research-associates-2-cra-ii-or-sr-cra
Home based, full-time, German & French required
Are you an experienced CRA, able to speak in German and French, interested in having international monitoring exposure?
Then we would like to invite you to explore this new opportunity from our Flexible Solutions Team, so you will be closely working with one of our main sponsors. Most of your sites will be in Germany, but you will also have monitoring responsibilities in France and Belgium.
Covance is one of the most stable, fastest growing global Contract Research Organizations, and we have supported the development of one-third of all prescription medicines in the market today and of 47 out of the 50 best-selling oncology drugs.
The work we do at Covance impact the lives of millions of people around the world… will you come and join us?
Location: Home based across Germany
• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
In lieu of the above requirement, candidates with four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
• Thorough understanding of the drug development process.
• Fluent in local office language and in English, both written and verbal. Additionally for this position French is required and any other language is an asset
Our ideal person is someone who…
• Brings minimum 3 years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) in international ph II-III, sponsor initiated trials.
• Brings a thorough knowledge of ICH Guidelines and GCP, a basic understanding of regulatory requirements and thorough knowledge of monitoring procedures. It is important the candidate has experience of complex studies and study submissions.
• Is fluent in German and French (and English), as this position will monitor across countries (main # of sites in Germany, but also some monitoring in France and Belgium)
• Is able to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
• Has 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
• Good communication and interpersonal skills
• Available for travel up to 60% of the time, including overnight stays as necessary
• Valid driving license
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.
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