Senior Clinical Research Associate
- Experience Level
- Experienced (non-manager)
SENIOR CLINICAL RESEARCH ASSOCIATES
In France, Germany and Italy
ROKC is currently working on several high profile pan-European clinical and Real World Data trials for a number of large pharmaceutical clients, in partnership with one of the largest infectious disease clinical networks in Europe.
At ROKC we offer a modern, positive and friendly working environment with opportunities to grow and take on more responsibility as part of a growing specialist CRO with a strong pipeline of innovative clinical trials.
We are looking to appointment a number of Senior CRA’s in France, Germany and Italy to add to our European monitoring team in support of our clinical studies across Europe. You can be based in the UK or in the country you are monitoring, travelling on a regular basis to our clinical sites either in France, Germany or Italy.
Languages are essential. You must have excellent spoken and written English plus one or more of the following languages: French, German or Italian.
As an integral part of the ROKC study team the successful applicant will have a variety of duties and will be responsible for performing site visits and monitoring activities at a senior level on Phase I-IV clinical trials in either France, Germany or Italy (in accordance with protocols, GCP/ICH Guidelines and other applicable regulatory requirements).
ROKC has a close working partnership with its main Sponsors and its network of sites. Site relations are, therefore, central to the success of our business. The ability to carry out all clinical site liaison tasks from site set up, ethical and member state regulatory submissions through to greenlight and SIV is essential. The objective being to ensure smooth, professional and, wherever possible, accelerated site activation. All types of site visits will be required to be undertaken including, but not limited to, qualification activities, initiation visits, interim monitoring visits, motivational visits, root cause analysis visits, audit support visits, and close out visits.
We operate modern risk based monitoring strategies and trial visits are carried out partly on a remote basis and part on site. Self-motivation, excellent organisational skills and a willingness to travel regularly, both domestically and internationally, is essential.
Other key duties:
- Assisting with document submissions to authorities applicable to the projects (ECs/IRB and CAs and Site Approval Groups
- Taking an active role in the project team by providing feedback and suggestions for successful completion of the project
Essential skills and experience:
- Significant evidence of work experience across the CRA function
- Understanding of the principles of ICH GCP and regulatory requirements
- Good oral and written communication in English
- Excellent organisational skills and personal presentation
- Experience working within a team environment under time and resource pressure
- Proven experience in clinical trials with knowledge of SOPs, regulatory reporting requirements and accepted practices
- Confident dealing with external and internal clients, vendors and agencies
- Languages are essential
- Fluent advanced command of spoken and written English and either French, German or Italian
- University degree in life sciences/pharmacy/nursing/biotechnology (UK accredited)
- A minimum of 2 – 4 years of independent monitoring experience (including pre- study, initiation, routine monitoring and close-out visits) according to protocol monitoring guidelines, SOPs, GCP/ICH Guidelines
- Excellent computer and i-device skills
- Ability to complete tasks in an accurate and timely manner
- Regular travel to European clinical sites throughout the year
- Full time permanent position based in the UK travelling across Spain on a regular basis
- Competitive salary £40,000 to £55,000(commensurate with experience)
- Benefits package, including company pension scheme
- Professional training and development support
- Applicants must be able to work full time in the UK and EU
- Support will be provided to EU candidates to meet any future UK employment requirements, should the UK leave the EU
To apply please upload a copy of your CV and contact details to:
Please note this is a permanent role and we cannot consider agency submissions or freelancers.
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