The Clinical Company
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Clinical Research Associate (BE)

24.04.2019 REF: O190045

Organization

Pharmaceutical company

Description of the Position

• Monitors activities conducted by clinical investigative sites as they relate to Sponsor clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Sponsor Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
• Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Sponsor Standard Operating Procedures (SOPs) and business processes.
• Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. Proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures regulatory inspection readiness at assigned clinical sites.
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and followup for all safety events by site personnel.
• Ensures safety and protection of study subjects through compliance with the study monitoring plan, Sponsor SOPs, ICH Guidelines, and applicable regulations.
• Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
• Manages investigator payments as per executed contract obligations. Negotiates investigator / hospital agreements with stakeholders. Maintain and complete own expense reports as per local and applicable guidelines.
• Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal Sponsor requests to assist in the placement of planned clinical studies with qualified investigators.

Demands of the Position

University degree in biological science or healthcare-related field
Prevous experience as a CRA.
Fluent in English, Dutch/French

Terms of Employment

The contract will initially be a contract with The Clinical Company, you will be outsourced to our client. Within The Clinical Company you will be part of a Benelux team of about 60 enthusiastic clinical professionals under the support of 2 dedicated Clinical Team Managers. Motivated, well trained and happy employees is essential to us in order to build a long lasting successful cooperation with our employees and clients. We therefore offer all the personal support you need, focus on your career development and make sure it’s fun to work for us!
Interested in this challenge and want to apply directly?! Please use the apply button below. For more information, feel free to contact Nick Dufour at 0032 (0)475 87 02 36 or n.dufour@theclinicalcompany.com.

Nick for Belgium

Didn’t find the right job on our website yet? Interested in an introduction of our company and what we can do to your career? Please feel free to contact me!

+32 475 87 02 36n.dufour@theclinicalcompany.com

Simone for the Netherlands

Didn’t find the right job on our website yet? Interested in an introduction of our company and what we can do to your career? Please feel free to contact me!

+316 12996359simone.polman@theclinicalcompany.com

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