Clinical Trial Associate
il y a 4 heures
Permanent
Full time
Hybrid (Brussel region)
The CTA will be delivering support to the Early-Stage Development Europe Operational team. He/she will be providing operational support and project support. This will include responsibility for in-house activities as well as for compliance with processes required to initiate, maintain, support, and close out the early-stage clinical trials managed by the department. He/she will also carry out tasks for the support of clinical grants.
**The company**
The company is a Clinical Research Organization specialized in clinical project management with a great values and corporate culture.
**The tasks**
For this hybrid role, the tasks will include but are not limited to:
- Assemble and provide support for timely Clinical Trial Submissions and availability of Essential Documents for clinical trials.
- Create Essential Documents Repository.
- Assemble and track availability of all essential documentation required for study conduct.
- Provide professional presentation of study materials for investigator/vendor or country operations meetings
- Liaise with sites and in house departments to ensure appropriate regulatory follow-up
- Organization and documentation (minutes) of project team meetings where need be
- Operational and project support activities
- Update, maintain and monitor CTMS to allow accurate project management, regulatory reporting and clinical grants payments
- Follow-up/check final accountability of IMP and return or destruction as appropriate
- Possibility for SME roles: CTMS, TMF steward, SIP, CLMS, Safety reporting tracking
- Review study budgets/clinical trial agreements for consistency with study protocol
- Updating of clinical and study planning database
- Review study budgets/clinical trial agreements for consistency with study protocol
- Clinical trial payments and payment tracking
- Compliance checks
- Maintenance of trackers
**Your profile**
- Bachelor degree (e.g. medical assistant, or paramedical education) or relevant work experience in clinical research field
- Advanced computer skills: e.g. professional using of MS Office programs for daily business including Excel
- Advanced communication skills (written and verbal) in local languages and English
- Understanding and knowledge of study protocols and study working documents, lab manuals, etc
- An understanding of the clinical research processes
- Preferably, an understanding of the ICH/GCP (international good clinical practice guidelines and harmonization) and local clinical trial regulations
**Salary**: €30,000.00 - €35,000.00 per year
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Bruxelles: Reliably commute or planning to relocate before starting work (required)
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