Trial Manager (field based - South Eng)
- Email: firstname.lastname@example.org
- Telephone: +44 (0) 191 282 0904
- Fax: +44 (0) 191 376 0748
- Address: Newcastle Clinical Trials Unit
1-4 Claremont Terrace
Nurse by profession trained at Guys and worked as District Nursing Sister in South East London, (Secretary in British High Commission in Trinidad and Tobago) Practice Nursing Sister in East Sussex and later Community Nursing Sister in Tenbury Wells, Worcestershire where undertook Masters in Clinical Practice. Moved into field of research within 3 Counties Cancer Research Network where worked as Trials Co-ordinator starting up portfolio at Worcestershire Royal Hospital and managing extensive oncology portfolio at Hereford County. Project led at Southampton Clinical Trials Unit to set up monitoring for portfolio of trials (Phase II&III) within CTU with final year field based. Researched and developed monitoring Risk Assessment Tool, author of SOPs for monitoring Risk Assessment, monitoring trials and co-author of Corrective And Preventative Actions (CAPA) for protocol deviations and GCP violations (including onward reporting of Serious Breach of GCP). Mentored Clinical Trial Co ordinators to monitor trials. Involved in trial management issues including formalizing the Trial Oversight Committees and facilitating Trial Steering Committee (TSC) - implemented MRC model and Charters for CTU. Instrumental in development CTU Consumer Steering Committee. Was member of Institute of Clinical Research CRA Special Interest Group – articles published in Feb 09 and Mar 10 in CRfocus to raise profile of monitoring of non commercial trials.
from July 2010 current post Trial Manager SPIRIT trials Field Based. Employed to work as first field based site monitor for Phase III, multi centre (146 sites), open label, prospective randomised SPIRIT trials and take responsibility for hospital sites in the South of UK. Working as part of SPIRIT team we have successfully completed SPIRIT2 recruitment 6 months early. Currently focusing on completeness and quality of data - source data verification of critical data entry (for final analysis) and completeness of SAE reporting.
- O'Brien SG, Hedgley C, Adams S, Foroni L, Apperley JF, Holyoake TL, Pocock C, Byrne JL, Seeley LM, Osborne WL, Goldman JM, Copland M, Clark RE. Spirit 2: An NCRI Randomised Study Comparing Dasatinib with Imatinib in Patients with Newly Diagnosed CML. In: 56th ASH Annual Meeting and Exposition. 2014, San Francisco, CA: American Society of Hematology.