James Goulding

James Goulding

Profile

Trial Management Lead for the department since November 2016, and previously a Clinical Trials Coordinator for six years within the department. I’ve worked in research for 13 years, including the set-up, coordination and oversight of clinical research within Rheumatology and Oncology. I have strategic oversight of the clinical trials administrative team, line-managing several members of staff. I endeavour to work to, and promote the standards of Good Clinical Practice across the department, working with clinicians, nurses and coordinators for a portfolio of 40+ academic & commercial trials. I have experience of working with a number of different NHS Trusts within the Yorkshire region, liaising with lead investigators, research staff, pharmacists and trials unit personnel. Ensuring we are at the necessary standards for monitoring, audit and inspection by external regulators is central 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 all clinical trials, both in-house academic and pharmaceutical-led within the rheumatology portfolio in Leeds at Chapel Allerton
•    Contribute to the strategic direction and development of the LIRMM portfolio, whilst maintaining an overview of all studies being accepted and forwarded for feasibility review and Clinical Service Unit (CSU) approval
•    Chair of the Research Oversight Committee (ROC)
•    Ensuring all studies are meeting the standards of ICH-GCP and alerting research teams to areas of improvement
•    Assisting with Sponsor-led audits & monitoring visits for both open and closed studies
•    Line management responsibility for several members of staff within the admin team including annual appraisal work
•    Upkeep, use and maintenance of clinical trial databases with all study information i.e. PPM and EDGE
•    Writing, disseminating & ensuring departmental SOPs are adhered to at all times
•    Extensive knowledge of research governance & legislative requirements notably ICH-GCP and the EU Directive, and providing expertise to all members of the department.

Responsibilities

  • Administrative lead for the Institute (LIRMM)

Research interests

  • Rheumatology, working primarily but not solely on rheumatoid arthritis trials. I 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
  • BA (Hons)

Professional memberships

  • PRINCE2 Practitioner

Research groups and institutes

  • Leeds Institute of Rheumatic and Musculoskeletal Medicine