Clinical Trial

il y a 10 heures


Antwerpen, Belgique Science Talents Temps plein

**Introduction**:

- Science Talents is part of House of Talents, an international HR services group specialized in bottleneck professions. You will be working in a no-nonsense environment where team spirit, drive and eagerness to learn are key.
We are very open and communicative go-getters who are keen on results and quality.
To further strengthen our growth, we are constantly looking for new colleagues within Project Staffing.
Working as a consultant equals working with a fixed contract at Science Talents. You get the chance to work on different projects in your field of expertise and gain new experiences in life sciences, the chemical sector, and the food industry.

**Job description**:

- The Clinical Trial & Quality Assistant assists the different departments and participates in the efficient, effective execution of clinical studies in the unit (GxP & applicable law and regulations compliant). The Clinical Trial & Quality Assistant executes multiple non-medical clinical trial related tasks.
Main Accountabilities

To assist the Quality Manager:

- To manage Curriculum Vitae and Job Descriptions for all the employees
- To manage the training curricula and user groups of the CPU personnel in the Learning Management System (Summit) and to develop training material (online training modules) and deploy them in Summit
- To support in audit and inspections: manage logistics, prepare backroom binders, assist with the preparation of information requests,
- Document Control Specialist: responsible for managing the procedural documents in the Electronic Document Management System. The Document Control Specialist is responsible for the instruction and must ensure that the other persons responsible for certain tasks in the life cycle of a document perform the necessary tasks (for example: training, notifying).
- Manage Basic Life Support training sessions
- Point of contact for on-call staff regarding training and qualifications
- Manage general documentation and study documentation (on site document room, archiving of physical and digital records)
- Coordinate Quality Control activities according to the CPU Quality Plan

To assist the Technology Manager:

- First line of support for IT issues
- Trouble shooting issues on site
- Update technology inventory on site
- Streamlining inventory for optimal usage

To assist the Study Managers:

- To support calendar management (meetings, training sessions, teleconferences, videoconferences, live computer meetings,...)
- To assist in team and project meetings and prepare meeting minutes
- To execute tasks required for the overall functioning of the unit
- To assist in the preparation and review of study specific documents: recruitment letter, study instructions, trial execution documents,
- To assist in activities related to the conduct of the trial (eg Verified Clinical Trial activities)
- To assist in the preparation of the Ethics Committee submissions in close collaboration with the Principal Investigator and lead Study Manager
- To ensure that the trial center file is maintained and that all relevant documents are filed correctly
- Preparation of screening visits, follow-up and ambulant visits
- To make relevant entries in the e-Source system

**Profiel**:

- Bachelor or Master degree (scientific or administrative)
- Strong interpersonal & administrative skills
- Ability to work as part of a team
- Enjoys the contact with healthy volunteers and patients
- Working knowledge of the execution of phase I clinical studies
- Able to effectively cope with strict deadlines and unexpected events
- Able to execute multiple tasks flawlessly
- Able to effectively prioritize tasks and to delegate if necessary
- Creative, flexible and having high ethical standards
- Attention for details
- Open to new concepts, innovation and change
- Computer literacy
- Fluent in written and spoken Dutch and English

**Offer**:

- Will you become one of us? Join a financially sound company and become part of a group of no fewer than 2,500 top colleagues We cannot wait to meet you Fill in the form below and we will reach out to you soon.
contract of indefenite duration, included:

- company car + fuel card
- Health insurance
- Meal vouchers of 8€ per day worked
- Net allowances
- Group insurance
- Smartphone subscription
- end of year bonus (13th month)
- Eco vouchers


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