Dan Harding has over eleven years' experience in clinical research, all in the CRO industry; 6+ years as a field monitor and 4+ years as a Lead CRA / Clinical Team Leader. Study phase experience includes Phases II - IIIb.
As a field monitor, my responsibilities included all aspects relative to monitoring clinical trials according to applicable regulations and sponsor and CRO SOPs. As a Lead CRA/Clinical Team Leader, my responsibilities have included, but are not limited to: assisting with proposal development; bid defense presentations; developing site feasibility materials; CRA interviewing/hiring; developing clinical monitoring plans, CRA training material, start-up metric tools, Operations Manuals and subject recruitment plans; presenting at Investigator Meetings; training sites and CRAs and; oversight of all clinical operations deliverables and field monitor performance. I've also worked closely with data managers in the development of electronic and paper CRFs and data checks and; performing QC of eCRFs and data checks. I've also contributed to the review and enhancement of revisions to SOPs, WPs, clinical monitoring templates and clinical trial management software.