Management of the Respiratory Clinical Trials Unit, with 25 years’ experience of effectively leading and directing Clinical Research Projects from inception through to completion.
Experienced in indications of: Asthma, Allergic Asthma, Chronic obstructive pulmonary disease (COPD), Viral Cough, Smokers Cough, Healthy Volunteers, Cystic Fibrosis, Bronchiectasis, Chronic Cough and Idiopathic Pulmonary Fibrosis (IPF). Most recently setting up and massively contributing to 5 Urgent Public Health Studies in Covid-19, with our unit becoming top recruiter in one of these global studies.
In my current role I work with numerous internal and external multidisciplinary agencies in the management and co-ordination of a diverse range of respiratory clinical research within the Clinical unit, contributing to national and international, drug development.
I take an active role in the recruitment, screening and follow-up of patients enrolled in to many respiratory projects. I co-ordinate the work of the medical, nursing and technical staff, both academic and clinical. Management and guidance of staff including a Clinical Trials Assistant, two Research Associates, four Research Nurses and a Clinical Trials Administrator, disseminating specific projects to the appropriate members of staff, monitoring their progress throughout to successful completion.
I oversee that all members of the team are performing to GCP standards required of the research projects. I am also responsible for all study set up, including feasibility and on many an occasion have taken a significant role in consultation of a research project and designing the study protocol.
Most of the studies the unit conducts are commercially sponsored however, we also have a number of in-house studies. On many of these projects I have been solely responsible for writing the protocol, information sheet, consent form etc and for completion of IRAS form application to the ethics, including attendance of the ethics committee meetings and application to MHRA.I have also written end of study reports to ICH GCP E6 standards, reporting on Eudract website and reporting on clinicaltrials.Gov.
I have authored a number of papers, and abstracts, presenting at the ATS, ERS, BTS and Allam Lecture. More recently I have developed an ECRF using the commercially available Medrio system, validating the ECRF, and setting up range checklists and skip links etc. In the last 3 years I have tutored medical students organising a week of training and patient interviews, culminating in supporting students with their presentations and marking their work.
Caroline is a Clinical Trials Manager with extensive experience and management skills and works for The University of Hull in Respiratory Medicine, a department dedicated to advancement of treatment and diagnosis of respiratory disease. Caroline had a major role in the departments conception providing a comprehensive out patients’ facility for the Hull Cough clinic, which has been the basis for a large number of clinical studies in the pharmacology of cough many of which Caroline has managed.