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Clinical Trial Coordinator - Belgium
Keyrus Biopharma (company)
Posted on : 06 December 2016
We are looking for a Clinical Trial Coordinator (CTC),to reinforce our Global Clinical Development services department (60 members). Active member of the Global Clinical Operations team, the CTC manages from start to finish, the operational aspects of medical research studies,
The main duties are:
- Management of Phase I to IV studies at a national and\or international level in collaboration with the Project Manager
- participation in submissions to regulatory authorities
- Preparation of study documents e.g. protocol, CRF, informed consent form
- Setting up of the procedures and guidelines
- Coordination of monitoring activities : training and follow-up of CRA, CRA management, respect of the monitoring specifications, respect of the project team objectives, study metrics follow-up, validation of monitoring reports, co-monitoring visits
- Reporting clinical operations status:tracking/issues to the Project Manager
- Ensuring the communication with the sponsor in collaboration with the Project Manager
- Coordinating with others clinical development teams i.e. regulatory affairs, biometry, safety department, ...
- Coordinating the logistic part of the clinical trial with the the various partners e.g. CROs, central laboratory, affiliates,...
- Respecting the quality commitments and participating in the continual improvement of the Quality System
- Life Science degree
- At least 2 years experience as Clinical Research Associate
- Excellent knowledge of ICH-GCP Guidelines
- Excellent communication skills
- Good command of office software (Excel, Word, PowerPoint)
- Team player
- Organised, pro-active, autonomous
- Good interpersonal skills
- Fluent in English, French and/or Dutch or any other language is an asset
- You also have the willingness to travel (1-5 times per year)
What we offer
You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…). Each employee will be welcomed with a varied integration program. We invest considerable time and resources in training our staff (technical and non-technical courses). You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who we are
We are a member of an international group, a European full-service Contract research organization (CRO) providing biopharmaceutical, nutritional, cosmetic, animal health and medical device industries with a broad range of clinical research services from early- to late-stage clinical development, including regulatory affairs, project management, clinical monitoring, scientific and medical support, site management, biostatistics, data management, product safety, quality assurance and medical & scientific communication.