Enroll-HD Regional Study Director EU/ANZ

• Jan 2023 - Present

European Manager Enroll-HD

• Mar 2013 - Jan 2023

Enroll-HD is a global observational study of Huntington’s disease (HD) acting as a platform to facilitate research into HD disease mechanisms, support the design and conduct of clinical trials and promote the development of evidence-based treatment guidelines. • Oversight of Enroll-HD study activities in 16 countries and 100+ sites across Europe.• Management of European sites and oversight of ongoing data quality in Europe.• Management of study start-up process including obtaining ethical and regulatory permissions. • Management of site agreements for Europe.• Training and ongoing management of regional coordinators and monitors across Europe. • Oversight of regional monitor activities for ongoing study data management.• Operational strategy design and production of operational SOPs • Design and production of key study documentation including operations manual, training guides, site initiation visit, interim monitoring visit and site assessment forms. • Design of electronic systems to manage study operations.• Management of translation programme for site and patient facing documents into 13 language Show less

UK Language Area Coordinator (LANCO)

• Jan 2011 - Mar 2013

The European Huntington’s Disease Network is a collaboration of Huntington’s Disease researchers and clinicians. The EHDN operates its own studies including a Europe-wide longitudinal observational study called REGISTRY, in addition to collaborating with CROs and Sponsors to support studies of investigational products. LANCOS provide operational support within a country, working as study monitors and in a variety of support roles for the network itself. My work included the following;• Training and ongoing support of REGISTRY site staff around the UK and Ireland.• Identification and set-up of new study sites.• Monitoring of site data at 32 sites around the UK. • Organisation and running of the annual conference for UK and Irish study staff.• Meeting coordination and support of the Surgical and Cognitive Working Groups.• Meeting coordination and support of the REGISTRY Steering Committee.• Support of the Registry Steering Committee Protocol Violations Sub-Committee. Show less

Research Assistant

• Oct 2007 - Dec 2011

• Site coordination of both drug trials and longitudinal observational studies.• Recruitment and testing of participants using a variety of cognitive assessments, structured and semi-structured clinical and behavioural assessments and functional assessments. • Responsible for SAE reporting.• Organisation of testing facilities and contracting agreements with the Wellcome Trust Clinical Research Facility.• Coordination of the regional outpatient’s specialist clinic for HD.• Cognitive, psychiatric and functional assessments for clinical purposes. • Recruiting, training and providing ongoing supervision of researchers within the group. Show less

Project Assistant

• Aug 2005 - Oct 2007

• Coordination of large scale epidemiological data collection (self-report data and biosamples with cohorts of 4000+ participants). • Data entry and database management.• Data analysis.• Recruiting and screening participants.• Designing study materials.• Review and analysis of medical record and death certificates data.• Supervising and training data entry workers