James Goulding

Profile

I’ve worked in clinical research now for over 17 years & have been the departmental Trial Management Lead since Nov 2016. Before this post I was a Clinical Trials Coordinator for 6 years here, primarily in trial set-up, and a Regulatory Officer prior to that at St. James’s within non-surgical oncology. I’m currently responsible for the oversight and conduct of clinical trials we manage within rheumatology, with additional oversight of dermatology and trauma & orthopaedics at Chapel Allerton Hospital. I lead the clinical trials administrative team, line-managing several trial coordinators, clinical trial assistants & an internal monitor. I endeavour to work to, and promote the standards of Good Clinical Practice throughout the department wherever possible, working with clinicians, nurses and coordinators alike across a portfolio of 80+ academic, commercial & non-commercial trials. I also have experience of working with a number of different NHS Trusts within the Yorkshire region, liaising with lead investigators, pharmacists and trials unit personnel. Ensuring we are working to the necessary standards for monitoring, audit and the likes of MHRA inspections by external regulators is core to my role. 

In brief, I have responsibility for:

•    Overseeing the administrative function of LIRMM, including leadership and management for all Clinical Trial Coordinators and Clinical Trial Assistants
•    Oversight of the MSK clinical trial portfolio, both in-house academic and pharmaceutical-led at Chapel Allerton
•    Contribute to the strategic direction and development of the portfolio, whilst maintaining an overview of all studies being recommended for feasibility review and Clinical Service Unit (CSU) approval
•    Chair of the Research Oversight Committee (ROC) & Operational Group (Ops) and core member of the CAH CSU Feasibility Committee & LIRMM Trial Management Group (TMG)
•    Ensuring all studies meet the standards of ICH-GCP and alerting research teams to areas of improvement where necessary
•    Assisting with Sponsor-led audits & monitoring visits for both open and closed studies
•    Line management responsibility for staff within the admin team including annual appraisal work
•    Upkeep, use and maintenance of clinical trial databases with all study information i.e. EDGE
•    Writing, disseminating & ensuring departmental SOPs are adhered to at all times within LIRMM
•    Extensive knowledge of research governance & legislative requirements notably ICH-GCP and the EU Directive, and providing ad-hoc expertise to all members of the department

Responsibilities

• Administrative lead for the Institute (LIRMM)

Research interests

• Rheumatology, working primarily but not solely on inflammatory arthritis trials. Also worked for 5 years in non-surgical oncology
• MSc dissertation title, the data for which will be published for a comparison of the TACT and TACT2 oncology trials was: '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