(Experienced) Clinical Trial Assistant

SolCur; Kontich; Sur place; EUR 32 000 - 46 000; Plein temps

Avantages offerts par ce poste

Competitive salary package

Flexible working hours

32 days of holiday

Full electric company car

Hospitalization and group insurance

Lunch vouchers

Eco vouchers

Mobile phone (data included)

Résumé du poste

A clinical research organization in Kontich is seeking an experienced administrative assistant to support the Clinical Research Team. The ideal candidate has at least 3 years of relevant experience, a Bachelor’s degree in a related field, and is fluent in English and another language. This role offers a competitive salary and flexible working options, including telework and extensive holidays.

Qualifications

• Minimum of 3 years of experience in a similar position within Clinical Operations.
• Experience with trial progress and metric systems.
• Knowledge of ICH-GCP and EU Directives applicable to Clinical Trials.
• Experience with trial progress and metric systems (CTMS, IRT, IXRS, eTMF).
• Knowledge of ICH-GCP and EU Directives applicable to Clinical Trials.
• Excellent organizational skills and detail orientation.
• Proficient in Microsoft Office and eager to work with databases.

Responsabilités

• Provide general administrative assistance to the Clinical Research Team.
• Prepare and update clinical trial related documents.
• Assist in submission packages to Ethics Committees.
• Assist in preparing submission packages to Ethics Committees/IRBs.
• Correspond with internal and external parties in English.
• Attend meetings and write minutes/reports.
• Arrange international travel and track records in the CTMS.
• Handle study supplies and shipments as needed.

Connaissances

Excellent knowledge of English

Knowledge of Dutch or French

Organizational skills

Team player

attention to detail

MS Office

Formation

Bachelor degree in Medical/Administrative assistant or equivalent

Outils

Microsoft Office

Clinical Trial Management System (CTMS)

IXRS

eTMF

Description du poste

The key purpose of the role is to assist the clinical Research team (CRA’s / CPM’s) in its day-to-day business. Working in a team environment, this position requires you are used to working close together with your team, your colleague CTAs as well as with other departments and stakeholders.

Main activities are:

• General administrative assistance to the Clinical Research Team (CRA’s, CPM’s, Medical department, …)
• Preparing, updating, follow-up of electronic filing of clinical trial related documents
• Preparing of study binders for site use
• Assisting in the preparation/submission of submission packages to the Ethics Committees/Institutional Review Board
• Correspondence with internal and external parties (mainly in English)
• Attending team meetings, writing meeting minutes and/or reports
• Arranging international travel
• Entering, updating and tracking of records in the Clinical Trial Management System
• Handling of study supplies (incl. shipments, tracking, …)

Qualifications

• You have a bachelor degree ‘Medical/Administrative assistant’ or equivalent by relevant experience
• Minimum of 3 years of experience in a similar position within Clinical Operations
• You have excellent knowledge of English and one additional language (Dutch/French)
• Experience with trial progress and metric systems (eg CTMS, Interactive Response Technology (IRT), Interactive Voice/Web Response System (IXRS), and eTMF)
• Knowledge of ICH-GCP and EU Directives applicable to Clinical Trials
• You have good organisational skills
• You have a profound knowledge of Microsoft Office
• You are interested in using multiple databases
• You are a real team player
• You are precise and have a great eye for detail

What we offer:

• We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charging card, hospitalization and groups insurance, lunch vouchers , eco vouchers, mobile phone (data included)
• We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, …)
• Side activities will be organised regularly, to achieve a close collaboration within our team
• We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
• We contribute to a number of charities & support the research and / or the patients in our industry.