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Lead Clinical Research Associate

  • Salary: £400 - £450 per day
  • Job type: Contract
  • Location: Amersham, Buckinghamshire
  • Sector: Other
  • Date posted: 07/07/2017
  • Job reference: J369390A

Lead Clinical Research Associate

Amersham + European Travel

£400-450pd

12 Month Contract

Requirement: English Speaking & one of - French / Italian / Spanish / Polish / Czech

I global leading healthcare company are looking for a Lead CRA to manage a remote global team of CRA's including the oversight of clinical studies, supporting project teams with planning & implementation of clinical trials in compliance with GCP, SOP and corporate policies & guidelines.

Main areas of responsibility/Duties and Responsibilities:

  • Line manage, train and oversee CRA contractors.
  • Responsible for managing site visit schedules, review and approval of site visit reports.
  • Manage study project plans and identify risks in meeting study milestones and to address resolutions of the issues with the project team as required.
  • Ensures that Serious Adverse Event (SAE) reports are provided to ensure compliance with reporting requirements.
  • Liaise with related functions/departments internally, e.g. Regulatory; Medical, Quality Assurance (QA); Safety unit; Finance; Contracts; Legal and Compliance.
  • Review of study data and follow-up with Data Management, Clinical Operations, Safety, Medical, Sites relating to electronic case report forms (eCRF).
  • Review of the e-Trial Master File (eTMF) and ensure it is up to date and accurate.
  • Attend site visits: Feasibility and Selection, Initiation, Monitoring and Co-Monitoring and Close-Out visits.
  • Ensures that the tracking system (patient recruitment; milestones; budget; vendor reporting) is up to date and provides management with detailed reports of clinical studies activities, as requested.
  • Lead CRA and clinical project meetings and provide regular verbal and/or written reports to project and management teams on the clinical study progress.

Demonstrable experience within clinical research & experience managing CRA's is needed for this opportunity.

Please apply within & contact Lottie Powell on 01179309760 for a further discussion about this lead CRA position.

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