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Freelance Senior Clinical Research Associate - Belgium

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United BioSource Corporation.

2021-12-03 09:02:34

Job location Amsterdam, Noord-Holland, Netherlands

Job type: fulltime

Job industry: Science & Technology

Job description

*This position will be home based in Belgium.*

UBC are looking to recruit a Freelance Senior CRA for an initial 6 months' project.

The successful candidate is familiar with the Belgian regulations and guidelines and has the ability to demonstrate a full knowledge of all aspects of the SCRA role.

You will have responsibility for studies/sites located in Belgium. You may be working on late phase studies, clinical trials or a combination of both. Ideally, we are looking for someone with experience in oncology and late phase studies, but this is not essential.

You will be familiar with study start-up, submissions to regulatory and ethics committees, negotiation of contracts, and have previous experience with all types of monitoring visits.

*Brief Description: *

You will ensure all studies are conducted according to the protocol, UBC and Sponsor SOPs, GCP and applicable regulatory requirements.

*Requirements:*

* Bachelor's degree - Life Science preferred or equivalent years of industry and monitoring experience
* At least 12 months active monitoring experience in Belgium
* Experience in electronic CTMS, EDC, eTMF
* Willingness to travel for the completion of on-site monitoring

*Specific Job Duties:*

* Thorough knowledge of regulatory requirements/ legislations applicable to clinical trials/ observational studies conducted in Belgium.
* Full knowledge and evidence of GCP training
* On site /remote monitoring visits
* Preparation, submission and tracking of local ethics committee and other regulatory applications as required.
* Contract and budget negotiation with hospitals and local R&D Departments
* Study feasibility assessments where required
* Dutch (Flemish) and French languages

#LI-REMOTE

*ABOUT UBC*

United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.

While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.

Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
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