Clinical Research Associate

Department Info

The objectives of the European Medical and Clinical Division are to organize, manage and conduct clinical trials by respecting all regulatory requirements and Good Clinical practice, to communicate clinical data to wider audience, to manage all medical aspects of company products, and to contribute to the new products and new therapies development.

Job Summary

As a Clinical Research Associate (CRA) you will be responsible for the preparation and monitoring of Clinical trials. Whilst fulfilling your role, you will be working in accordance with all relevant guidelines, protocols, regulatory requirements and Standard Operating Procedures (SOP’s) of Terumo. Additionally, you will act as a representative of the company, follow up on the SOP’s and provide a monthly reporting towards the management, as you will be reporting directly to the Clinical Project & Team Manager.

Job Responsibilities

As our Clinical Research Associate (CRA), you are 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 Terumo.

By fulfilling your role, you will be involved in the 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 and online data verification according to the monitoring plan, you will fosters effective relationships with investigator site staff to ensure that clinical metrics are met. When issues occur, you will proactively and promptly implement corrective action plans, and consult the project manager and EMCD management if necessary.

Your duties also include the 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. Additionally, you will ensure the integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines.

The job duties can be categorized into different fields, which need to be managed efficiently and maintained continuously:

1. Preparation of Clinical Trials

2. Regulatory

local regulations and center specific requirements

3. Clinical trial monitoring

4. General

Profile Description

You have obtained a Master’s degree in relation to a scientific background, preferably related to Life-sciences. An equivalent through experience within a similar role will also qualify.

You can look back on at least 2 to 3 years of experience within a similar role. Previous experience concerning clinical trials is a must.

Being experienced in Oncology, Cardiology and/or Peripheral Endovascular Diseases will be regarded as an asset. In addition previous experience related to Regulatory Affairs and within the medical devices industry will both be a definite plus as well.

You are experienced in working within an international environment. Consequently, you thrive within an international and multicultural environment.

You posses an eye for detail and strong organizational, as well as communication skills. You are proactive, a team player and a self-driver.

You are fluent in English and preferable one other language. This entails both verbal and writing skills.

You are willing to travel when it is required, up to 30%.

Offer

Working for Terumo means contributing to society through healthcare. We offer a full-time employment contract accompanied by an attractive salary package.

We offer a work environment that supports Terumo’s core values: Quality, Respect, Care, Creativity and Integrity. A work environment in which every associate, customer and business partner is treated with respect, where sincerity is key and where everyone always strives to find the most optimal solution. Furthermore, you will find yourself in an environment that promotes a mindset that embraces challenge for the future.

Interested in using your administration and communication skills to support our passionate teams? Interested to find out more? Take a look at Terumo Europe’s Corporate Video or at our website !

Contact Person

Jarne Jans.