Clinical Research Associate in Germany

My client, an international company, seeks contract Clinical Research Associates (CRA) for urgent office based roles near Dusseldorf, Germany.

These are 12 month contracts at a minimum of 0.5 FTE and preferably 1.0 FTE.

The successful candidate will have 2 years prior experience of working as a CRA in either a contract or permanent role. Although experience of contracting would be beneficial, we can assist you in setting up as a contractor if you have not undertaken this type of role before.

The successful candidate will undertake routine monitoring on behalf of our clients.

RESPONSIBILITIES

• Develop and write trial protocols and present to steering committees
• Design case record forms (CRFs)
• Manage ethics committee and regulatory authority applications
• Locate and assess suitability of facilities at a study centre
• Liaise with clinical staff and Principle Investigators (PIs) on conducting the trial
• Set up the study centres
• Train site staff to industry standards
• Monitor the trial throughout its duration, which will involve visiting the study centres on a regular basis
• Confirm source data/document verification (SDV)
• Collect completed CRFs
• Write, file and collate trial documentation and reports
• Ensure all unused trial supplies are accounted for
• Close down study centres on completion of the trial
• Discuss results with a medical statistician
• Archive study documentation and correspondence
• Prepare final reports and occasionally manuscripts for publication

SKILLS AND QUALIFICATIONS

• Excellent German and English language skills (written, spoken and reading)
• Strong organisational skills and time management skills
• Excellent interpersonal skills both written and verbal
• Ability to confidently communicate with an array of internal and external contacts
• Excellent attention to detail
• Willingness to undertake 60% travel for monitoring purposes
• Extensive knowledge of Microsoft based packages and database applications such as Access and Excel
• Thorough knowledge of ICH-GCP guidelines and the EU Clinical Trials Directive
• A Life Sciences Degree

Call Quinton at Prime Pharma on 0207 318 5856 for further details or email me at qnortje@primepharmapeople.com