We are appointing an experienced Senior Clinical Research Associate, to cover our operations in France, as part of our European monitoring team, in support of our clinical studies across Europe. You can be based in London or France, travelling on a regular basis to our clinical sites across France.

 

Languages are essential. You must have excellent spoken and written French and English.

 

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 on clinical trials in France, as well as other territories as necessary (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 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 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

• Early phase and respiratory experience are desirable.

 

Requirements:

• Excellent fluent spoken and written French and English language is essential

• University degree in life sciences/pharmacy/nursing/biotechnology

• A minimum of 2 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

 

Additional Information:

• Full time permanent position

• Competitive salary £40,000 to £50,000 (commensurate with experience)

• Benefits package, including company bonus, pension scheme and private healthcare

• Professional training and development support

• Applicants must be eligible to work in the United Kingdom and EU

• Applicants can be based in France or United Kingdom

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To apply please upload a copy of your CV and contact details

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