Clinical Research Administrator

2 weeks ago


Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Gruppe Full time
About this role:

The In-House Clinical Research Associate (CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO's mission of building a world-class shared clinical technology, process innovation, and clinical operations team, in partnership with the company's divisions, through technology enablement, high-touch customer service, study acceleration, and high-quality data collection.

Key responsibilities:
  • Conduct clinical trial site start-up activities related to the preparation and approval of regulatory documents, ensuring they are conducted consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures.
  • Collaborate with Regulatory Affairs for Competent Authority (CA) submissions and approvals and other site start-up support activities, as applicable.
  • Provide support in enrollment, follow-up, and closure of clinical trial activities.
Requirements:
  • Bachelor's Degree, or an equivalent combination of experience and education.
  • Fluency (written and spoken) in English, a 2nd language will be a plus and highly considered.
  • Must be comfortable interacting with clinical research site personnel via phone and email.
Preferred qualifications:
  • Research Coordinator or In-House Clinical Research Associate / Clinical Research Associate / Study Start-up specialist experience.
  • Experience working with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems / eTMF.


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