This is a fixed term position - 12 months
UBC are looking for a SCRA with at least 2 years monitoring experience in France and preferable 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.
At UBC you will also be directly involved in site contract and budget negotiations. This is a great opportunity for a CRA from a large CRO background to gain new skills if you have no previous experience.
If you are looking to gain new skills and exposure to other phases with reduced travel, UBC may be just the place for you! Brief Description:
Monitors in accordance with ICH, GCP, CFR guidelines, UBC and project SOPsSpecific Job Duties:
Desired skills and requirements:
- Thorough knowledge of French legislation applicable to clinical trials/ observational studies and ICH GCP
- On site /remote monitoring visits
- May be required to support / mentor junior CRAs
- Preparation, submission and tracking of local ethics committee and other regulatory applications
- Contract and budget negotiation with hospitals
- Study feasibility assessments where required
- Bachelor's degree - Life Science preferred or equivalent years of industry and monitoring experience
- At least 2 years active monitoring in France
- Experience in electronic CTMS, EDC, eTMF
- Minimum travel -approximately 30% depending on study allocation
- Good written and verbal communication skills, in English and French
- Ability to work independently and in a cross-functional team
- Excellent organizational and time management skills
- Highly self-motivated and proactive, with keen attention to detail
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.
You can find out more by visitingwww.ubc.com