Senior CRA - Home based in Italy
- Experience Level
- Experienced (non-manager)
UBC are looking for a SCRA who has experience of study start-up and is familiar with working in Italy. 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 be directly involved in site contract and budget negotiations, IRAS/EC submissions and all aspects of study monitoring. This is a great opportunity for a CRA from a large CRO background. If you are looking to gain new skills and exposure to other phases with reduced travel, UBC may be just the place for you!
Monitors in accordance with ICH, GCP, CFR guidelines, UBC and project SOPs
- Bachelor’s degree – mandatory Life Science background or equivalent years of industry and monitoring experience
- Experience in electronic CTMS, EDC, eTMF
- Minimum travel – approximately 20% depending on study allocation
Supervisory Responsibilities: Mentoring new and/or junior CRAs, if needed
Specific Job Duties:
- Thorough knowledge of Italian legislation applicable to clinical trials/ observational studies and ICH GCP.
- On site / remote monitoring visits
- Preparation, submission and tracking of local ethics committee and other regulatory applications, including online submissions for interventional studies, if required
- Contract and budget negotiation with hospitals and local R&D Departments
- Study feasibility assessments where required
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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