Clinical Research Professional
Clinical Project and Study Management
Clinical Research Associate/Monitoring
Unblinded Monitoring Services
Study/TMF Rescue
Virtual CRA Services/ Support
ICH/GCP Auditing
Nursing Services
ADHD Nurse Practitioner/Assessor
Non-Medical Prescriber
Registered General Nurse - Adult
Experience in ITU, Forensic Nursing, Urgent Care, Primary & Secondary Care
Research Nursing
Emergency Nurse Practitioner
Experience working with Pharmaceutical/Biotech companies for nine years. Roles have included Project Manager, CRA, Senior CRA and Lead CRA and a Research Nurse on different projects, working within Primary Care, Secondary Care and Commercial Research Centres. Experience of Phase I (unblinded monitoring only) to phase IIIb studies. Experience of completing all aspects of Clinical Project Management and site management including feasibility, site selection, pre-study contract/budget negotiations using the NIHR industry costing template working with hospitals and local R&I departments. Also completed site set up and initiation, independent site monitoring, Pharmacy IMP management and accountability, remote monitoring and site closure.
Nurse Practitioner and Independent Nurse Prescriber with 18 years experience of Nursing within the NHS and Private Sector. Most recently working in GP Practice as a Locum ANP, predominantly seeing and treating patients in their own homes as well as within the GP Practice dealing with minor illness, injury and chronic disease management.
Clinical Project Manager
Managed three complex study programs that included a novel COPD study, a fully remote phase II hospital and home-based trial in SARS-CoV-2, which included the management of a virtual team.
Led and managed the core cross-functional study team for the operational delivery of clinical studies.
Co-ordinated and participated in meetings with the study team, vendors, stakeholders and sponsors.
Designed project plans according to contract and protocol deliverables.
Forecasted financial activity for projects and had regular meetings with the company finance director and project accountant.
Analysed, recommended and implemented improvements to Clinical Project management processes.
Preparing informed consent forms, protocol amendments and other study and patient-facing documentation, completing Ethics and Regulatory submissions.
The coordination and planning of recruitment targets to focus the study and project teams to meet their recruitment targets, reviewing recruitment strategies every week if unmet targets. This work was integral to delivering recruitment for the study four months ahead of schedule.
Completed accompanied field visits to assess CRA performance, provided retraining or support where applicable, and reported findings for further action as required.
Highly skilled at using Excel and other Office 365 applications. Developed protocol monitoring tools, visit calculators, and trackers to increase efficiency for CRAs and sites. This reduced the risk of missed visits/protocol deviations and was shared across the project team.
Assisted with the development of the eCRF, recommended changes to make the system more efficient and user friendly, and performed UAT where applicable.
Writing and reviewing monitoring visit reports, ensuring these were completed within timelines and that follow-up items were resolved at each visit.
TMF Rescue
Senior Clinical Research Associate
Completed all aspects of site management, including site selection, pre-study contract budget negotiations, site set up and initiation, and independent site monitoring.
Working to strict timelines to prepare for data locks for an interim analysis with the data safety monitoring committee and final data lock.
Maintenance of study files and the TMF/eTMF completing regular filing.
Excellent organisational skills and contributed to reviewing and adapting systems to improve efficiency.
Manage accruals and finances for several sites ensuring payments are made per contract.
Worked on Phase II - IIIb multi-centre studies, completed both onsite and remote monitoring.
Acted as a Lead CRA, managing a team of 7 CRAs, completing monthly 1:1 calls. Offer support and guidance to assist in resolving any issues the team may have, ensuring that the team meets critical deadlines.
Aesthetic Practitioner (Anti Wrinkle Injections and Prescriptions)
Flu Vaccinations (Private Clinics)
Advanced Nurse Practitioner and Non Medical Prescriber with ENP qualification.
Primary Care - walk in centre, minor injuries, GP Practice including home visiting and out of hours.
Telephone Triage (Dr First).
Systems used: EMIS, EMIS Web, EMIS Anywhere, Vision, Maxims, System1, Adastra and iSOFT).
Experience in Cardiology and Critical Care.
Forensic/Custody Nursing (Merseyside).
Research Nurse
Training
Cyber Security Awareness
Level 3 Safeguarding Adults & Children
Duty of Candour
GCP Auditing Principles and Practice (RQA)
ICH/GCP | GDPR
DipHE Adult Nursing
BA (Hons) Health and Social Care
ENP and Non-Medical Prescriber
Indemnity
Professional Indemnity Insurance
Public Liability Insurance
ICO Registered
Francis, N. et al. (2023) 'Feasibility of home administration of nebulised interferon ß-1a (SNG001) for COVID-19: a remote study,' BJGP Open, 7(4), p. BJGPO.2023.0089. https://doi.org/10.3399/bjgpo.2023.0089.
Monk, P. et al. (2021) 'Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial,' The Lancet Respiratory Medicine, 9(2), pp. 196–206. https://doi.org/10.1016/s2213-2600(20)30511-7.
Reviews
There are not many people I can think of to use the word 'inspirational' but for you it is perfect! Thank you so much for not only working extremely hard over the last 3 months, but also with coming up with some brilliant ideas for making everyone more efficient, and for sharing with the team this week. It was a great forum for you to share and you certainly shone!!!! Well done Ang, I think you have really inspired the team! SH, Team Manager