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Clinical Quality Assurance – Career Development Opportunities

TMQA is looking to expand its team of Clinical Quality Assurance (CQA) professionals.

Your Background

Applicants should have a minimum of 3 years’ relevant experience.  This experience will ideally be in CQA, however, we are also keen to offer career development opportunities to applicants in other areas of clinical research (eg. CRAs) who would like to move into CQA.

The Job

The major part of the job will be undertaking audits of clinical trials, usually at investigator sites.  The job will involve travel in the UK and Europe with the possibility of travel further afield.  Typically you will conduct two audits per month each of which will involve 2-3 days on site.

Relevant experience in clinical trials is essential as well as an ability to work independently (after initial training).  You will have the personal skills to interact professionally with clinical research staff at all levels.  A key element will be to analyse the evidence gathered during the audit and present findings clearly and concisely both verbally and in a written report.


We have offices in Edinburgh and Bratislava.  Staff who are transitioning into QA would need to be based in one of these offices.  Home-based positions will be considered for staff who are already experienced CQA Auditors.


For further information please contact

New MHRA Inspectorate Blog

The MHRA Inspectorate blog is aimed at those organisations that are inspected by MHRA and need to keep up to date with the latest thinking and guidelines.  

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EMA Tightens Rules on ‘Revolving Door’ for Committee Members and Experts

The EMA has tightened its rules on declarations of interest by committee members and experts by restricting the involvement of experts in the scientific assessment of medicines if they plan to take up a job in the pharmaceutical industry. The EMA’s updates also include a revised guide on how to complete the EMA’s declaration of interest form. The EMA’s declaration of interest policy aims to restrict the involvement of experts with possible conflicts of interest in the EMA’s work while maintaining EMA’s ability to access the best available expertise. The EMA considers that employment in a pharmaceutical company is incompatible with an involvement in the EMA’s activities. Whenever a member of a scientific committee or working party informs the EMA that he/she intends to work for a pharmaceutical company, the EMA will immediately restrict the member from any participation from evaluation of medicines. In March 2014, the EMA management board endorsed a major revision of EMA’s policy on handling declarations of interest for scientific committee members and experts. The revision took into account input form stakeholders at the EMA’s September 2013 public workshop “Best expertise v conflicts of interests: striking the right balance”. It entered into force in January 2015. The EMA will continue to review its policy on a regular basis.

Addendum I to GVP Module XVI Released for Consultation

Addendum I to Good Pharmacovigilance Practice (GVP) Module XVI was released by the EMA last month for public consultation. The deadline for comments is 30 June 2015 with Q4, 2015 being the expected date for coming into effect. GVP Module XVI relates to educational materials. This addendum provides guidance for marketing authorisation holders on the submission of draft education materials to the competent authorities of the EU Member States as well as guidance for these competent authorities on the assessment of these materials, particularly regarding format and content, and guidance on publication of educational materials by marketing authorisation holders on specific websites. In line with the release of this addendum, the introductory cover note on GVP was updated.

FDA Publishes BIMO Inspection Metrics

The FDA recently published the annual bioresearch monitoring (BIMO) inspection metrics for fiscal year 2014. The inspectional data covers all aspects of the FDA’s BIMO program, including clinical investigators, institutional review boards (IRBs), sponsors, bioequivalence and good laboratory practices (GLP) for all centres (ie. CBER, CDER, CDRH, CFSAN, CVM). A summary of the metrics from inspections of clinical investigators, IRBs, sponsors/monitors/CROs is provided below:

  • Clinical investigators - 58% resulted in no action indicated (NAI), 37% resulted in voluntary action indicated (VAI) and 5% resulted in official action indicated (OAI). The most common deficiencies were as follows:

o   Failure to follow the investigational plan and/or regulations

o   Protocol deviations

o   Inadequate record keeping

o   Inadequate accountability for the investigational product

o   Inadequate communication with the IRB

o   Inadequate subject protection – failure to report AEs and informed consent issues.

  • IRBs – 50% resulted in NAI, 45% resulted in VAI and 5% resulted in OAI. The most common deficiencies were as follows:

o   Inadequate initial and/or continuing review

o   Inadequate SOPs

o   Inadequate membership rosters

o   Inadequate meeting minutes

o   Quorum issues

o   Subpart D issues

o   Inadequate communication with CI/institution

  • Sponsors/monitors/CROs – 57% resulted in NAI, 35% resulted in VAI and 8% resulted in OAI. The most common deficiencies were as follows:

o   Inadequate monitoring

o   Failure to bring investigators into compliance

o   Inadequate accountability for the investigational product

o   Failure to obtain FDA and/or IRB approval prior to study initiation.