Do you actively want to contribute supporting drug development, in one of the biggest biotech companies, with an amazing pipeline? Then this job as Clinical Trial Assistant might be for you !
Job Description
As a Clinical Trial Assistant (NL/EN or FR/EN or NL/FR/EN) you will provide support for all study-related activities.
Responsibilities:
- 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
Key Activities:
- 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
Requirements
- Scientific degree
- 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
- Language skills: very good knowledge of Dutch + English OR French + English. Trilingual is a plus
- Clinical trial process experience
- Work involving data entry into systems/databases and/or business support
- Attention to detail
- Time management & prioritization
- Flexibility
- Relationship management
- Organizational Skills
- Written and oral communication skills
- Good working knowledge of common software packages
- Data analysis and presentation
- Problem solver
- Teamwork
- Project Management (organization and prioritization)
- Existing right to work in Europe required
Benefits
- A balanced salary package based on your skills and experience
- Work - Life balance : 2 days/week on site
Vacancy number: 20135
