James Goulding

Profile

I have worked in clinical research in Leeds for 19 years, acting as the Institute Trial Management Lead since 2016. Prior to this, I worked as a Clinical Trials Coordinator in rheumatology at Chapel Allerton Hospital and as a Regulatory Officer at St. James’s University Hospital and Cookridge Hospital for non-surgical oncology.

I am responsible for the oversight and conduct of clinical trials being managed within rheumatology, whilst offering additional oversight of the dermatology and trauma & elective orthopaedics portfolios. I’m the lead within the LIRMM clinical trials administrative team, with line-management responsibility for Clinical Trial Coordinators, Clinical Trial Assistants & the MSK Research Governance and Training Lead. I endeavour to work to, and promote the standards of Good Clinical Practice throughout the department, working with clinicians, nurses and coordinators alike across a portfolio of 100+ academic, commercial & non-commercial studies. In addition I’ve worked with a number of different NHS Trusts within the Yorkshire region, liaising with lead investigators, pharmacists and trials unit personnel. Ensuring LIRMM is working to the necessary standards for monitoring, audit and external inspections i.e. by the MHRA (Medicines Healthcare Regulatory Agency) is core to the role. 

In brief, main responsibilities include:

•    Overseeing the administrative trials function of LIRMM, including leadership, guidance and management of the Clinical Trial Coordinators and Assistants
•    Oversight of the MSK clinical trials portfolio - both investigator initiated and pharmaceutical-led trials at Chapel Allerton
•    Contributing to the strategic direction and development of the portfolio, whilst maintaining an overview of all studies being put forward for feasibility review and Clinical Service Unit (CSU) approval
•    Core membership of the LIRMM Trial Management Group (TMG); LIRMM Research Oversight Committee (L-ROC); CAH CSU Feasibility Committee & Operational Group (Ops), plus a deputy for Clinical Trials to the LIRMM Senior Management Team (SMT)
•    Ensuring studies meet the standards of ICH-GCP, alerting research teams to any area of necessary improvement as appropriate
•    Assisting with Sponsor-led audits & monitoring visits for open and closed studies
•    Line management responsibility for staff including annual SRDS appraisal work & 1:1s
•    Upkeep, use and maintenance of clinical trial databases holding key study information i.e. EDGE & the oversight of annual recruitment accrual metrics for the Institute
•    Writing, disseminating & ensuring departmental & Sponsor QA SOPs are adhered to by staff within LIRMM
•    Extensive knowledge of research governance & legislative requirements, most notably ICH-GCP and the EU Directive & providing ad-hoc expertise to staff members as required

Responsibilities

• Clinical Trials Admin Team Lead for the Institute (LIRMM)
• LIRMM Trial Management Group
• CAH CSU / LIRMM Feasibility Core Member

Research interests

• Rheumatology, with a particular interest in inflammatory arthritis. Additionally 5 years in non-surgical oncology at the Yorkshire Cancer Research Network (YCRN) working with NHS Trusts in Yorkshire including: Leeds; Mid-Yorks; Harrogate; York; Huddersfield; Airedale & Bradford
• MSc dissertation title, the data for which will be published for a comparison of the TACT and TACT2 oncology trials: 'What impact does adjuvant breast cancer chemotherapy-associated toxicity have on patients' quality of life? An analysis of the TACT2 trial dataset'

Qualifications

• MSc in Clinical Trials
• BA (Hons) in History & Sociology

Professional memberships

• PRINCE2 Practitioner

Research groups and institutes

• Leeds Institute of Rheumatic and Musculoskeletal Medicine