Contract CTA (hybrid)

£200 - £220 per day
  1. Contract
  2. Clinical Trial Assistant (CTA)
  3. United Kingdom
London, England
Posting date: 06 Feb 2024
58775

Proclinical are recruiting for a Contract CTA to join a small biotech. This role is on a contract basis with the option to go permanent and is located in London.

Responsibilities:

  • Serve as a main point of contact for the clinical team for allocated project discussions, correspondence, and affiliated documentation.
  • Partake in the generation of presentations as required for projects, divisional, sponsor and/or business development requirements.
  • Assist both CRA's and any others with preparing, managing, and delivering clinical trial supplied and keep track of information.
  • You will arrange, enable and offer logistical assistance for the study team, scheduling meetings, delivering agendas, and writing minutes.
  • Contribute to study-specific or vendor audits performed by sponsors or regulatory agencies, and reply to audit observations, when needed.
  • Offer general support and assistance to the international clinical operations division as well as to CPM(s).
  • Support the clinical operations teams in accomplishing all necessary tasks to meet divisional and project objectives.
  • Lead project teams with trial progress tracking by updating the clinical trial management systems.
  • Responsible for submitting system requests for the clinical operations teams and vendor representatives when suitable.
  • Perform initial proposal QC in Veeva Vault and support in accomplishing quarterly QC of the TMF.
  • Other duties may be assigned.

Key Skills and Requirements:

  • Educated to a degree level in a biological or scientific field and/or a mixture of experience and education.
  • Familiarity in a similar role within a biotech, pharmaceutical or CRO as well as in an R&D setting.
  • Previously works sponsor-side at a biotech ad/or pharmaceutical organisation.
  • Acquaintance with handling electronic TMF, which involves set-up, upkeep, QC/QR and query management, as well as with DIA reference model.
  • Expertise on ICH/GCP and suitable guidelines.
  • Prior involvement with cell/gene therapy clinical trials as well as hematology/oncology clinical trials.
  • Capable of handling various tasks and multifunctional resourced simultaneously with a high attention to detail.
  • Able to respond to quick changes in priorities and aggressive timelines.
  • Familiarity in conducting inspection promptness actions.
  • Computer literacy.
  • Acquaintance with eDC systems, such as Rave EDC.
  • An organised individual with planning capabilities.
  • Communication skills both verbally and in writing.
  • Willing to travel for business needs.

If you are having difficulty in applying or if you have any questions, please contact Matthew Pike at m.pike@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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