Based in the Greater Manchester area, Lingualogic provides specialist language services and regulatory support for clients from healthcare, medical/life sciences and the pharmaceutical industry. Lingualogic is able to provide specialist language services thanks to the expertise and experience of Dr. A. Karen Schafheutle, a bilingual (German/English) translator and interpreter with a solid background in medical/healthcare research.
2011 MA (Distinction) Translation and Interpreting Studies, The University of Manchester
2007 PhD Epidemiology, The University of Manchester
Thesis: The Epidemiology of Functional Gastrointestinal Disorders
1996 MSc Environmental Analysis and Health Dissertation: An assessment of Molewatch, the first Australian-style sun awareness campaign in the UK 1993 BSc Environmental Biology
Relevant Experience 2011 Karen has been providing specialist language services for many years. Since founding Linguaglogic Language Services, she has been working as a Translator/Interpreter specialising in the medical/scientific/pharmaceutical fields.
2001 - 2011 University of Manchester
Having previously gained experience in clinical research at the MRC Environmental Epidemiology Unit in Southampton, working on a study into the epidemiology of Paget's Disease of Bone (as the Procter& Gamble Research Fellow 1996), Karen moved to Manchester in 2001 after being awarded an MRC Studentship to complete a PhD on the Epidemiology of Functional Gastrointestinal Disorders at the Arthritis Research Campaign Epidemiology Unit (now Arthritis Research UK Epidemiology Unit). Part of a larger project into chronic pain conditions, this study investigated the psychosocial factors associated with the onset of FGIDs, as well as assessing predictors of consultation behaviour and chronicity. The study was a prospective population-based cohort study with additional follow-up of consulters in primary care, and involved 11,000 patients registered with three general practices in the South Manchster area. Karen's experience with this large population study, including the close collaboration with GP practices and the challenges associated with governance approval procedures, stood her in good stead when she took the position of Trial Manager of theHTA Health Technology Assessment-funded study ACT NoW (Assessing the Effectiveness of Communication Therapy in the North West), a study that combined a pragmatic multi-centre randomised controlled trial, a qualitative study and a health economics evaluation. Not only was she responsible for the successful coordination of this multi-centre study, including managing a large team, she was also responsible for leading the research team throughout the numerous challenges faced during the feasibility phase of a study, including successful grant applicatons, applications for extensions in time and funding and a successful application for substantial NHS Subvention funding. Karen also sat on the Trial Management Group and was invited by the NHS Health Technology Assessment Program to join the study’s Trial Steering Committee.
Her experience as a Trial Manager led to her appointment as Research Practice and Governance Manager. Based in the University's Central Research Office, Karen became the key point of contact for all issues relating to standards and expectations in research practice and research governance. Amongst other things, she was responsible for
Maintaining and developing University policy and guidance on good research practice, developing policy, systems and processes for University assurance of the quality and standards of research practice and research governance
Developing a system for monitorin all University-sponsored and co-sponsored clincal trials
Proving advice and training to staff and students relating to regulatory complaince, research ethics, research governance, GCP guidelines and so on
Acting as advisor to the investigation panel in formal investigations of allegations of misconduct in research made against members of the University
Other roles and achievements included
Leading the University of Manchester through a statutory MHRA Good Clinical Practice Inspection
Member of the University of Manchester's MHRA Inspection Steering Committee
Member of the University of Manchester's Research Ethics Oversight Committee
Member of the Greater Manchester Research Alliance's Sub-Committee responsible for developing the MAJIK (Monitoring and Audit Joint Inspection Kit) Monitoring Tool and the MIRRA (Manchester Integrated Risk Assessment) risk assessment tool, both of which were adopted by the Medical Research Council as part of their Data and Tissues Tool kit (http://www.dt-toolkit.ac.uk/organisations&policies/researchmanagementtools.cfm)
Awards for publications and posters (including the 2006 Winter Verna Wright Prize for a Poster Presentation at the SRR Winter Meeting 2006 in Manchester and the Main prize at the Local Stroke Research Network Meeting in January 2007 in Aintree).
Karen left her position at the end of August 2010 in order to start an MA in Translation and Interpreting, also at the University of Manchester. She was awarded the degree of Master of the Arts with Distinction in November 2011.