Carol Davis-Wilkie
Cambridge,Cambs
Summary
Accomplished professional with expertise in trial management, ethical submissions, and safety reporting. Demonstrates strong skills in compliance monitoring and project management, ensuring meticulous attention to detail and effective time management. Proficient in adverse event reporting, with a proven track record of problem solving. Committed to advancing career goals within the clinical research field by leveraging core competencies to enhance operational efficiency.
Overview
38
38
years of professional experience
Work history
Clinical Trial Coordinator
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire
2015.01 - 2025.06
- Day to day trial management, including communicating with sites for 4 trials involving over 22 sites.
- Training and set up of new participating sites.
- Submission of ethical and regulatory applications and amendments.
- Management of site remuneration/invoicing and funder-required reporting.
- Safety reporting to Sponsor, Ethics and Regulatory Authorities.
- Coordinated trial activities in compliance with CCTU SOPs and ICH GCP.
Healthcare Assistant (Bank Staff)
Cambridge University Hospitals NHS Trust
Cambridge, Cambridgeshire
2017.08 - 2025.03
- Cared for patients in wards and out-patient clinics, ensuring patient dignity and privacy at all times.
- Ensured infection control measures were adhered to strictly for a safe environment for both staff and patients alike.
- Monitored vital signs of patients with attention to detail for accurate readings.
- Kept detailed records of patient progress in EPIC electronic notes system.
- Escalated issues to Nurse In Charge as required.
Senior CRA (Clinical Research Associate) II
PPD (Pharmaceutical Products Development)
Cambridge, Cambridgeshire
2011.10 - 2015.01
- Conducted site monitoring visits to verify constant adherence to Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Conducted interim monitoring and close-out visits for hospital-based Phase III oncology trials.
- Experienced working with with PPD's CTMS system, Medidata Rave EDC, Bracket IVRS, and Cenduit IVRS systems.
- Ensured protocol adherence, resulting in accurate and reliable data collection.
- Communicated any concerns or issues promptly to senior management team.
- Maintained confidentiality of subject records, upholding ethical standards at all times.
- Facilitated trial progression to meet project timelines efficiently.
- Maintained professional relationships with research teams, fostering collaboration.
- Resolved study related queries effectively, ensuring smooth operation of trials.
- Managed trial documentation, ensuring high level of accuracy.
- Detected protocol deviations, using appropriate channels to report and escalate incidents.
- Maintained site documentation, performing Case Report Forms (CRF) reviews, source document verification and query resolutions.
Associate Clinical Supplies Programme Manager
Merck Sharp and Dohme UK
Hoddesdon, Hertfordshire
2008.11 - 2011.09
- Project managed forecasting and supply of study medication to meet Clinical Team Needs
- IVRS set-up and management of an international Phase IIB study involving 600 patients
Senior Clinical Research Associate (CRA)
Merck Sharp and Dohme UK
Hoddesdon, Hertfordshire
2000.12 - 2008.11
- Clinical trial site selection, monitoring and close-out for pivotal osteoporosis trials, including MHRA Inspection.
- Clinical trial monitoring of diabetes and hyperlipidaemia trials.
Clinical Research Assistant (CRA)
Merck Sharp and Dohme UK
Hoddesdon, Hertfordshire
1996.04 - 2000.11
- Clinical trial monitoring for osteoporosis, diabetes and hyperlipidaemia trials.
Medical Information Scientist
Merck Sharp and Dohme UK
Hoddesdon, Hertfordshire
1995.05 - 1996.04
- Answered queries by phone and in writing from medical professionals and patients regarding MSD products.
Medical Information Scientist
Amgen UK
Cambridge, Cambridgeshire
1992.12 - 1995.01
- Answered queries by phone and in writing from medical professionals and patients regarding Amgen products.
- Completed ABPI Code of Practice medico-legal review for sales materials, documents, leave-pieces, and advertisements.
Senior Medical Information Officer
Lederle Laboratories
Gosport, Hampshire
1990.12 - 1992.01
- Answered queries by phone and in writing from medical professionals and patients regarding Lederle products.
- Completed ABPI Code of Practice medico-legal review for sales materials, documents, leave-pieces, and advertisements.
Medical Information Officer
Lederle Laboratories
Gosport, Hampshire
1988.12 - 1990.01
- Answered queries by phone and in writing from medical professionals and patients regarding Lederle products.
- Completed ABPI Code of Practice medico-legal review for sales materials, documents, leave-pieces, and advertisements.
Junior B Medical Laboratory Scientific Officer
North Middlesex Hospital
Edmonton, Haringey
1987.12 - 1988.01
- Conducted biochemistry testing, analysis and reporting of human blood samples in a busy laboratory.
Education
A-Levels - Language and Literature
Not known
Gosport, Hampshire /1992 - /1993
Bachelor of Science - Human Biology
Oxford Polytechnic (Now Oxford Brooke's University)
Oxford, Oxfordshire /1983 - /1986
9 O levels, 3 A levels - A levels in Physics Chemistry and Biology
Secondary Education
London /1978 - /1983
Skills
- Trial management
- Ethical submissions
- Safety reporting
- Compliance monitoring
- Project management
- Problem solving
- Attention to detail
- Time management
- Adverse event reporting
- Patient consent procedures
Affiliations
Grade III and IV in classical guitar.
References
References available upon request.
Timeline
Healthcare Assistant (Bank Staff)
Cambridge University Hospitals NHS Trust
2017.08 - 2025.03
Clinical Trial Coordinator
Cambridge University Hospitals NHS Foundation Trust
2015.01 - 2025.06
Senior CRA (Clinical Research Associate) II
PPD (Pharmaceutical Products Development)
2011.10 - 2015.01
Associate Clinical Supplies Programme Manager
Merck Sharp and Dohme UK
2008.11 - 2011.09
Senior Clinical Research Associate (CRA)
Merck Sharp and Dohme UK
2000.12 - 2008.11
Clinical Research Assistant (CRA)
Merck Sharp and Dohme UK
1996.04 - 2000.11
Medical Information Scientist
Merck Sharp and Dohme UK
1995.05 - 1996.04
Medical Information Scientist
Amgen UK
1992.12 - 1995.01
Senior Medical Information Officer
Lederle Laboratories
1990.12 - 1992.01
Medical Information Officer
Lederle Laboratories
1988.12 - 1990.01
Junior B Medical Laboratory Scientific Officer
North Middlesex Hospital
1987.12 - 1988.01
A-Levels - Language and Literature
Not known
/1992 - /1993
Bachelor of Science - Human Biology
Oxford Polytechnic (Now Oxford Brooke's University)
/1983 - /1986
9 O levels, 3 A levels - A levels in Physics Chemistry and Biology
Secondary Education
/1978 - /1983