Candidates

Clinical Research Associate

A Clinical Research Associate (CRA) sets up, monitors and completes clinical trials.

A clinical trial is a scientific study of the effects, risks, efficacy and benefits of a medicinal product. These need to be carried out before a product reaches a hospital or the shelves of the local pharmacy. Trials are undertaken at various stages, or 'phases', and include: trials on healthy humans; trials on patients with a disease; and studies conducted after the launch of a new product to monitor safety and side effects during large-scale use.

Clinical trials are conducted by pharmaceutical companies or contract research organisations (CROs) on their behalf.

Typical work activities

  • Developing and writing trial protocols (outlining the purpose and methodology of a trial);

  • Presenting trial protocols to a steering committee;

  • Designing data collection forms, known as case record forms (CRFs);

  • Co-ordinating the ethics committee, who safeguard the rights, safety and wellbeing of all trial subjects;

  • Managing regulatory authority applications and approvals, who oversee the research and marketing of new and existing drugs;

  • Locating and assessing the suitability of facilities at a study centre;

  • Briefing doctors/consultants (or investigators) on conducting the trial;

  • Setting up the study centres, which includes ensuring each centre has the trial materials and checking that the investigator knows exactly what has to be done;

  • Monitoring the trial throughout its duration, which will involve visiting the study centres on a regular basis;

  • Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV);

  • Collecting completed CRFs from hospitals and general practices;

  • Writing visit reports;

  • Filing and collating trial documentation and reports;

  • Ensuring all unused trial supplies are accounted for;

  • Closing down study centres on completion of the trial;

  • Discussing results with a medical statistician, who usually writes technical trial reports;

  • Archiving study documentation and correspondence;

  • Preparing final reports.

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Job of the week - Senior Contract Regulatory Professional

Our client is a leading Pharmaceutical company. This R&D group have a large and dynamic European Regulatory Affairs Department responsible for the regulatory affairs work for the CNS R&D in Europe, Turkey, CEE region, Israel, South Africa, New Zealand and Australia.

The work has several aspects;

  • Communication to the Global Regulatory Teams and the supporting functions for regulatory submissions, such as clinical;
  • Working with the local operating companies within the^allocated region and external communication to regulatory authorities in the regions and to the EMEA. The group covers both developmental compounds not yet licensed and the maintenance and further development of marketed products. The prime responsibility for compounds is with the European Regulatory Liaison (EURL) who is responsible for the regulatory activities in the region and inputs to the global regulatory aspects for the compound.Regulatory consultants will work for an EURL or a global regulatory leader in the CNS therapeutic area or in the mature products area. They will work on the practical aspects of the compounds assigned from clinical trial applications (CTA’s), ASR’s, requests for scientific advice, MAA preparation, variations, renewals, PSURs etc depending on the life cycle of the compounds assigned. They may work on one or several compounds depending upon the work required for any compound at the time. Their work will be assigned and monitored by the EURL or theglobal regulatory lead responsible for the consultant.Eligibility to work in the EEA is required