Clinical Research Associate - Leuven, België - Terumo Europe

Terumo Europe

Geverifieerd bedrijf

Leuven, België

4 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

At Terumo, we enhance lifesaving medical technologies for the benefit of society.

Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise.

You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are driven by respect, ownership and continuous improvement. It is at the heart of everything we do. This is how we make a difference in the lives of patients, customers and associates._

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.

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

Site assessments preparation of the materials for clinical trials
Preparation of files for the submission to Ethical committee, Competent Authority and other bodies if needed
Preparation and management of Clinical trial documentation
Followup of agreements with hospitals and investigators
Technical preparation of Investigators and Steering Meetings
Check the status of patient enrolment and milestone followups 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 closeout visits
Source data verification online and onsite
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 SOP's
Act as a representative of the company.
Monthly reporting to management.

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 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