Express Scripts Senior Clinical Research Associate (home-based) in Amsterdam, Netherlands

Brief Description:

Are you a Senior CRA/ CRA looking for a change? Are you experienced in Phase III clinical trials and would you like to learn more about the different types of Late Phase studies across various therapeutic areas?

Yes? You may be the CRA we are looking for!

Who are we:

United BioSource Corporation (UBC) is a mid-size international provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our diverse suite of services helps bridge the gap between development and delivery and builds brand loyalty through patient access and adherence

We are currently looking for a Senior CRA (or CRA ready for the next step) in theNetherlandswho may be either experienced in late phase studies or keen to get involved in this phase of the clinical trial process.

We work with some of the Top 10 Pharma and small to mid size pharma/ biotech companies in a wide range of interesting therapeutic areas.

Specific Job Duties:

  • Involvement in Feasibilities and Start up of studies assigned
  • Preparation of study documents and support in submissions
  • 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 visit reports 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
  • 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

Requirements:

  • Bachelor’s degree requiredand /or othermedical / biological science qualificationorrelevant workingexperience
  • 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

If you are interested in a CRA job at UBC, our Talent Acquisition team would be very interested to hear from you!

*LI-AF1-UBC