Senior Clinical Research Associate - Home based in Spain
- Experience Level
- Experienced (non-manager)
This is a Freelancing position
Are you a (Senior) CRA looking for a change/ OR ready for a new exciting opportunity in an international environment working as part of a dynamic team? Are you interested in early phase trials and would you like to learn more about the different types of Late Phase studies across various therapeutic areas? Do you have experience with onsite and remote monitoring?
Well, then YOU might be the (Senior) CRA we are looking for to join our EU team!
Specific Job Duties:
- Involvement in Feasibilities and Start up of studies assigned
- Preparation of study documents (ICF adaptation to local law) and management/ support in EC/RA submissions and contract negotiation with sites
- Assist in the preparation of study specific procedures and guidelines
- Responsible for all aspects of Site Management and Monitoring of clinical studies from initiation through close out, including onsite visits and remote monitoring
- Completion of Monitoring Reports (PSSVs, SIVs, IMVs/ Remote Monitoring, COVs) and Site management; and tracking in CTMS and other systems within requested timelines
- Working with a local and international project teams
- Responsible for data review as per project specifications
- Review and maintenance of regulatory documents as per study and local requirements
- Responsible of the ISF/eTMF
- Liaise between the sites and project teams and establish good communication and relationship
- Ensure data integrity by conducting Source Document Verification of CRF data against medical records/pharmacy records etc.
- Monitor subject safety by preforming safety reviews/SAE reconciliation and assure appropriate action is taken at the investigative site in accordance with the appropriate policies and SOPs, as well as ICH-GCP guidelines and local regulations
- Ensure ethical conduct of clinical studies
- Bachelor’s degree required and / or other medical / biological science qualification or relevant working experience
- Minimum of 24 months active monitoring experience
- Good knowledge of medical terminology
- Good written and verbal communication skills, in English and other language(s) as appropriate for country
- Ability to perform tasks in CTMS, EDC, eTMF and client specific systems (if applicable)
- Thorough knowledge of ICH GCP
- 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
- Ability to travel on business as and when 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.
You can find out more by visiting