Clinical Research Associate (Cell Therapy)

Highly Competitive
  1. Permanent
  2. Clinical Research Associate (CRA)
  3. United Kingdom
London, England
Posting date: 01 Jul 2020
30264

An opportunity has opened for an experienced Clinical Research Associate to join an ambitious biotech company in West London. You will become one of the members of a close-knit team, responsible for all aspects of study site management. It is an ideal role for an experienced CRA who has early phase, oncology study monitoring experience, preferably in the cell therapy arena.

Job Responsibilities:

  • Expedite the site qualification and study site initiation processes including the conduct of Site Qualification and Site Initiation visits
  • Independently perform monitoring visits including site initiation, qualification, routine monitoring and close out visits
  • Manage multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory
  • Ensure quality of data submitted from study sites, collect data from sites within established timelines and ensure timely follow up/submission on any requested information
  • Work across functions in the Company to ensure the readiness of supply kits
  • Review adverse event reports (where required) and ensure site reporting of safety events in a timely manner
  • Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner
  • Interact and build professional and collaborative relationships with all study personnel (study coordinator, investigator, pharmacist & cell therapy team members), peers and office-based personnel
  • Identify evaluate, and recommend potential investigators/sites on an on­ going basis to assist in the placement of planned clinical studies with qualified investigators
  • If required, prepare, coordinate and present at Investigator meetings and other study trainings

Skills and Requirements:

  • Bachelor's degree (BSc, BA or RN equivalent) in biological or science-related field is essential
  • Minimum of 3-5 years' monitoring experience, working as a CRA.
  • Experience in monitoring oncology early phase studies (including ATIMPs an advantage)
  • Ability to establish and maintain effective working relationships
  • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements
  • Excellent communication, interpersonal and organisational skills
  • Effective problem-solving skills
  • Computer literacy, proficiency in Microsoft Office. Preferably experienced with the use of eCRFs

To Apply

In case you have difficulty in applying or if you have any questions, please contact Jack O'Neill at 0203 846 0646 or upload your CV on our website - www.proclinical.com/send-cv

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