Clinical Research Associate

Vacature Clinical Research Associate

As a CRA, you will manage clinical trials in different phases and different therapeutic areas:
- You manage projects from start to finish: you carry out pre-study visits, you initiate the project, you are responsible for routine monitoring and closing visits about the quality standards and timelines
- You obtain and update essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations both in a Trial Master File (eTMF) and Investigator Study File (ISF)
- You actively participate in Local Study Team meetings
- You contribute to the selection of potential investigators
- You train, support and advise investigators and site staff about study-related matters
- You contribute to National Investigators meetings
- You initiate, monitor and close study sites in compliance with Procedural Documents. You share information on patient recruitment and study site progress with Local Study Teams
- You are in charge of performance at the site. You proactively identify study-related issues and find the appropriate solutions
- You update IMPACT and other systems with data from centers, respecting deadlines
- You manage study and drug supplies and track the drug accountability at the study sites
- You carry out source data verification according to the SDV plan
- You ensure data query resolution on site
- You are responsible for accurate and timely reporting of Serious Adverse Events on site
- You prepare activities related to audits and regulatory inspections together with the local Study Team Lead and the CA&A
- You provide the required monitoring visit reports, meeting the requested deadline
- You work with Data Management to ensure the quality of the study data
- You ensure compliance with the company’s Code of Conduct and policies and procedures concerning people, finance, technology, security and SHE (Safety, Health and Environment)

Profiel Clinical Research Associate

- You have at least 1 to 3 years of experience with monitoring
- You obtained an Master's degree in one of the Life Sciences
- You are fluent in Dutch, French and English (written and spoken skills)
- You dispose of advanced knowledge of MS Office and particularly Excel
- You have strong communication skills and are able to build relations with the on-site staff and the internal staff (LDL, CRAs, CTAs, medical advisor etc.)
- You are flexible and easily adapt to new ways of working or new projects
- You are capable of working independently
- You can set and manage priorities
- You are well-organised and able to work efficiently and effectively in a dynamic environment

Contact

Please contact us for more information on +32 16 309 509 or hello@arcq.be

Locatie

Brussel

Opdrachtgever

ARCQ

Publicatiedatum

07.11.2017

Publicatie eindigt

06.01.2018

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