Senior Clinical research associate (CRA) medical devices - English/Spanish

For one of our clients in Leuven we are urgently looking for an experienced Clinical research associate (CRA).

You will have a hybrid role which involves site management and project support. Since a lot of the sites are Spanish speaking, a fluent knowledge of Spanish is required. Monitoring is mostly remote, you will have a lot of communication with the sites. International travel is limited, however.

Interested? Apply as soon as you can!

Job Description 

The Clinical Research Associate (CRA) is ultimately responsible for the successful management of investigator sites throughout the site lifecycle, whilst working in accordance with ISO14155 guidelines, the study protocol, applicable local and international regulatory requirements and Standard Operating Procedures of our client

The CRA’s involvement includes site feasibility stage, with responsibility for the successful start-up of a study and management of the site right through to close-out. In addition to planning and conducting various site visits (feasibility, site selection, interim monitoring and close-out) and online data verification according to the monitoring plan, the CRA fosters effective relationships with investigator site staff to ensure that clinical metrics are met. When issues occur, the CRA proactively and promptly implements corrective action plans, and escalates to project manager and EMCD management if necessary.

The duties of Clinical Research Associate include preparation for and attendance of investigator meetings, coordination of the timely shipment and the subsequent proper storage and accountability of clinical supplies and follow-up of any safety issues that have occurred at site. The Clinical Research Associate (CRA) ensures integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines.

Taking the complexity of the EMEA headquarters of a division of an important Japanese corporation, a global leader in the health care business, the job duties can be categorized into different fields.

Responsibilities 

1. Preparation of Clinical Trials
• Site assessments preparation of the materials for clinical trials (Investigational plan, Investigators brochure, Patients information,...)
• Preparation of files for the submission to Ethical committee, Competent Authority and other bodies if needed
• Preparation and management of  Clinical trial documentation
• Follow-up of agreements with hospitals and investigators
• Technical preparation of Investigators and Steering Meetings
• Check the status of patient enrolment and milestone follow-ups in hospitals and feedback the status to investigators and study management periodically
• Clinical trials monitoring
• Provide assistance to global Clinical and Regulatory personnel
• Assistance in audit preparation

2. Regulatory
• Be compliant with the regulations related to the conduct of Clinical Trials according to international guidelines, local regulations and center specific requirements

3. Clinical trial monitoring
• Perform feasibility visits
• Perform site initiation, FUP and close-out visits
• Source data verification on-line and on-site
• Verification of inconsistencies on the case report forms
• Source documentation request
• Data cleaning (including but not limited to queries formulation and resolution)
• Preparation of presentations
• Preparation of Newsletters

4. General
• Follow the Internal SOPs
• Act as a representative of the company
• Monthly reporting to management

Profile 

• Master Life-science degree or equivalent by experience
• Experience as Clinical research associate
• Experience in medical devices is an asset
• Must be able to work in  an international environment
• Fluent in English ans Spanish
• Ability to function in a self-directed manner with a high degree of independence
• Travel flexibility
 

Contact Information 

Hilde Wolput
hilde.wolput@valesta.com
015 21 11 04

Application form : Senior Clinical research associate (CRA) medical devices - English/Spanish

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