Clinical Research Assistant

Clinical Research Assistant

Ref: 62| Posted: 14th Nov 2022

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Terumo Aortic are currently looking to recruit a Clinical Research Assistant on a FTC for 12months. This is an excellent opportunity to develop your career whilst making a real difference.

The main responsibilities of the role are;

  • Assist the Clinical Affairs Department with Clinical Investigation/study and Post Market Clinical Follow Up (PMCF) activities taking responsibility for defined elements of projects.
  • Work in compliance with ICH GCP, the Medical Device Regulation, ISO 14155, internal procedural documents and any other relevant regulatory requirements
  • requirements
  • Undertake training to develop competency in compliance with ICH
  • GCP, the Medical Device Regulations (MDR), ISO 14155, internal
  • procedural documents and any other relevant regulatory
  • requirements
  • Create, develop, and maintain departmental Standard Operating Procedures (SOPs)
  • Processing of Study related finance activities (invoice processing and tracking)

Clinical Studies

  • Create, circulate and file accurate meeting minutes including any action follow-up
  • Process incoming adverse event reports from PMCF or studies
  • Assist in the preparation of clinical trial documentation, including Investigator Site File (ISF) preparation and shipping
  • Process data requests from internal personnel and external parties
  • Perform other administrative duties as required within the department
  • Undertake any necessary training to enhance job performance
  • Responsibility for clinical research department input to specific CER's
  • Prepare and present internal and external presentations
  • Aid with regulatory submissions
  • Take responsibility for ensuring compliance with relevant regulatory standards in defined work areas
  • Other activities as required to support Clinical Affairs Deliverables
  • Maintain department files
  • Implementation, set up and maintenance of Trial Master File (TMF/eTMF) including any applicable Clinical Trial Management Systems (CTMS)

The successful candidate will possess;

  • Administrative experience in a similar field
  • Previous experience of working in a medical device company (Desirable)

Basic knowledge of GCP, ISO14155 and Medical Device Regulations