Interested in taking your first steps in the fascinating world of clinical research? Do you actively want to contribute supporting drug development in one of the biggest biotech companies with an amazing pipeline? Then this is the job for you!
As a Clinical Trial Assistant you will provide support for all study-related activities.
- Supports the execution of clinical studies
- Responsible for study start up activities
- Tracks study related documents
- Manages logistics and document exchange between clinical sites and our company
- Actively contributes to results oriented department goals
- Drives continuous improvement of GSO
- Identifies opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness
- Updates Clinical Study Management Systems
- Responsible for study start up activities, including creating site folders, collating, preparing and maintaining eSIP documents, updating systems
- Tracks and maintains adequate study related supplies in the office and facilitate their distribution to sites, including preparing and distributing Study File Binders and Site Initiation presentations/materials
- Ensures collection, review, track and provision of appropriate clinical documents to support regulatory and EC/IRB submissions
- Coordinates the preparation of the submissions and local tracking of applications and submission of IND safety reports to IRB/IEC as applicable and to central Research Ethics Boards (Canada & US)
- Processes, reconciles, distributes and tracks essential documents and submits them to the archive in compliance with the company SOPs
- Orders, processes and tracks Case Report Forms (CRF) and Patient Reported Outcomes (PRO)
- Participates in organizing Investigator meetings and monitor workshops as required
- Coordinates entry and maintenance of local data into study management systems
- Completes tracking documentation as applicable, including but not limited to, spreadsheets and study trackers
- Provides study administrative support to the country study team (Project Manager, Contract Manager, CRA) as required, including generation of study status reports
- Provides support to responding to local audits and inspections
- If required, set-up/maintains Courier Accounts and organizes sample shipments
- Develops and maintains as appropriate to their role an effective relationship with local Regulatory Affairs to ensure consistent working practices for EC/IRB & Regulatory submissions
- Participates in Local Study Team Meetings
- Prepares draft Informed Consent Form for Project Manager review if applicable
- Participates in GSO workshops and local study meetings, gives updates and take minutes as required
- Supports the feasibility process as required
- Supports any activities related to Centralized Monitoring as required
- Coordinates translation of documents when required
- If required, performs the Data Steward role
- If required, performs a buddy/mentor role for new CTAs
- Bachelor in the life sciences.
- Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company. Previous experience as CTA is a plus.
- Clinical trial process experience
- Work involving data entry into systems/databases and/or business support
- Attention to detail
- Time management & prioritization
- Relationship management
- Organizational Skills
- Written and oral communication skills
- Language skills: Very good knowledge of Dutch, French and English
- Good working knowledge of common software packages
- Data analysis and presentation
- Problem solver
- Project Management (organization and prioritization)
- A balanced salary package based on your capabilities and experience.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 17458