Freelance - CTA - Belgium - Home Based - 1FTE - 12 months - Single sponsor outsourced
i-Pharm Consulting are seeking on behalf of a leading Global CRO a Freelance CTA to be out sourced to a single sponsor and start immediately. Office based contract ideal for someone based in Gent, Belgium.
Other duties include:
- Coordinate the preparation and/or review of all operational trial-related documents (e.g., forms, guidelines).
Coordinate the preparations and/or review of site related documents (e.g., Investigator Site Files (ISF).
· Coordinate the preparation and distribution of the clinical study documentation (e.g., site communication, newsletters, pocket brochures, appendix 16 for the Clinical Study Report (CSR)).
· Coordinate the delivery and inventory of study related non-clinical supplies (ordering, distribution, tracking, expiry dates management, resupplies).
· Coordinate site contracts finalization and execution.
· Coordinate Insurance certificates for the trial in collaboration with legal department.
· Ensure completeness and maintenance of key trial information in the Clinical Trial Management System(CTMS).
· File and upload documents in the different systems as needed.
· Ensure accurate maintenance, and archiving of the electronic Master File (eTMF) within the required timelines and contribute by performing ongoing quality checks/review.
· Function as a Study Owner in the eTMF when required.
· Assist in reviewing and providing feedback of Standard Operations Procedures (SOPs), Working Instructions (WISs) and processes.
- Schedule and organize functional group meetings and/or events as needed.
Support the Clinical Operations group as needed, including the Global Strategic Sourcing Group (e.g. Contracts execution and shipment, Resource Request management, coordination of the providers contracts, processing of invoices in the system).
· Perform other duties as assigned.
Home based flexibility - Gent, Belgium
Competitive hourly rate
12 months, 1.0 FTE (full time)
- Minimum 1 years of clinical research experience
- Degree in Life Sciences/ Pharmacy/ Biotech
- Strong written and verbal Dutch, French & English
About i-Pharm Consulting
i-Pharm Consulting is a global specialist recruitment company servicing the pharmaceutical industry. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.
If you would like to discuss this vacancy further, please call Youssef Maachou on +31 20 808 14 84, or email email@example.com. If this role is not suitable, Youssef is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
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