The CRF Team consists of 30 full time, permanent staff including Physicians, Nurses, Project Management, Clinical Research Assistants, Laboratory Technicians, Recruitment Specialists, Scientific Co-ordination, Data Specialists and Clerical Research Assistants.
The team is also supported by an excellent team within Research, Development and Innovation which incorporates a Business Team dealing with costings and contracts, as well as a Governance Team which supports us with Quality and Regulatory processes.
A few of the individuals within the team are detailed below but we are happy to provide you with similar information about any of the team that you are likely to encounter either as a Volunteer or a Sponsor.
Dr Richard FitzGerald
CRF Director & First In Human PI
Dr Richard FitzGerald is the Director of the CRF and a Consultant Physician in Clinical Pharmacology and Therapeutics / General Medicine at the Royal Liverpool University Hospital. He is a qualified first-in-man principal investigator as part of the CRF’s MHRA Phase I accreditation.
Richard has been involved in early phase clinical trials for over 10 years, including periods working in industry. He has been a director of the CRF since 2011 and has been principal investigator on many early phase and first-in-man studies (including patient cohorts and healthy volunteers) over the last five years. Richard has particular interests in the design and analysis of early phase trials in patient groups and the development of novel pharmacodynamic techniques to generate proof of principle in both healthy volunteers and patients.
Richard is also an honorary senior lecturer in the Wolfson Centre for Personalised Medicine, where his major research interests include stratified therapies in cardiovascular disease, optimisation of anti-platelet therapy, adverse drug reactions and systematic reviews and meta-analyses.
Senior Early Phase Trials Scientific Coordinator
Carolyn is the Senior Early Phase Trials Scientific Coordinator based in the CRF. Her role involves working closely with the CRF Director and Principal Investigators to support the translation of basic and pre-clinical science into early phase clinical trials, developing, designing and implementing these to the highest levels of participant safety as well as scientific and data quality within the CRF.
Since graduating with a degree in Biochemistry with Medical Biochemistry for the University of Leeds Carolyn has worked within industry and academia and has experience of many aspects of clinical research, from pre-clinical testing through to Phase IV trial delivery.
Previous employment has included over 5 years working at the University of Liverpool’s Clinical Trials Research Centre, and stints in laboratories in both Contract Research Organisations and industry. Carolyn has always been passionate about clinical research and is excited to be part of a team that delivers high quality participant-focused care built on a solid foundation of cutting edge science and stringent adherence to all ethical, regulatory and legal requirements.
Zalina is the Clinical Manager for the CRF. Her role involves co-ordination of the CRF on a day to day basis including planning, allocation and evaluation of work carried out by her team. Zalina has management responsibility of the clinical and laboratory teams within the CRF. Her role also is to ensure there is staffing cover over the 24hr period, ensuring a high standard of nursing care and that all clinical research activity is compliant and conducted in accordance with EU Directive ICH GCP and the agreed protocols.
Zalina has a Diploma in Adult Nursing and qualified as a registered nurse in the year 2000. Her career began working as a staff nurse on a Geriatric ward. Following this Zalina worked 7 years as a staff nurse on a Bone Metabolics unit. Zalina took on the role as the Deputy Manager on the CRF in 2009 and then was appointed in her current position as the Clinical Manager in 2010.
Operational Support Manager
Jenn Gibney is the Operational Support Manager for the CRF. Jenn has management responsibility for our non-clinical staff including project management, recruitment, data officers and research clerical staff. Jenn also has a major responsibility for the safe and efficient scheduling of studies into the CRF.
Jenn has been employed on the CRF for over 7 years; working in a variety of different roles including: CRF Administrator, Data Entry, Research Assistant, Logistics Manager, culminating in her current position as the Operational Support Manager.
Jenn is currently studying with Open University to complete a BSc (Hons) Health Sciences, with an expected completion date of September 2017.
Kate is the Recruitment Manager for the Clinical Research Facility. Kate has responsibility for the recruitment of volunteers and patients for the unit. This includes ensuring there are strategies in place to meet recruitment to time and target, exploring new and innovative ways to increase recruitment, and developing partnership working with community and primary care organisations.
Kate’s career started as a Pharmacy Technician and in 2007 she moved into research within the National Institute of Health Research (NIHR) Clinical Research Networks. During this time Kate completed an MSc in Clinical Research at Liverpool University. Kate joined the CRF in January 2017.
Senior Research Nurse
Becky is the Senior Research Nurse on the Clinical Research Facility. Her role involves coordination of early phase studies including protocol development, study set up, recruitment and ensuring studies are compliant to ICH GCP. This includes supporting the clinical team with setting up research projects on the CRF to ensure a streamlined approach to set up activities. She is a GCP Facilitator and currently facilitates Introduction to GCP sessions through the NIHR CLRN network.
Becky has a Diploma in Adult Nursing and a Post Graduate Certificate in Leadership and Management. Previously she has worked as a post-operative cardiothoracic surgical nurse. In 2011 she began working as a Research Nurse on the Clinical Research Unit where she developed her knowledge and experience of conducting Phase 1 Clinical Trials. She was appointed to her current position in July 2018.
Senior Data Manager
Susie is a Band 7 Clinical Research Senior Data Manager at the Clinical Research Facility. Her role is to develop the Data Management strategies for the unit, as well as database development and training. Susie has over 15 years’ experience working in Health informatics and Clinical Research for both Liverpool Primary Care Trust and the University of Liverpool, Clinical Trials Unit.
Karen is the Project Manager on the Clinical Research Facility. Her role involves the co-ordinating of the Early Phase CRF led Clinical trials. Responsibilities typically include contributing to the development and management of the protocol, budget, timeline, quality guidelines and being the primary point of contact for the Sponsor. Her role also compiles and drives documentation for the project, ensuring the accuracy and quality of regulatory data including Ethics Submissions
Karen has a 1st class BSc (Hons) degree in Business Management and has worked for the NHS for over 16 years. In 2010 she began working as a Research Facilitator for the National Institute for Health Research (NIHR), where she developed her knowledge and experience of conducting Research within the NHS. Karen was appointed to her current position in April 2016.
Colin is the Laboratory Manager for the CRF. His role involves the co-ordination of laboratory procedures relating to current and upcoming clinical trials. This includes assisting with initial study set up through to sample processing, storage and dispatch. He is also responsible for the upkeep and maintenance of all laboratory equipment on the unit and is a designated COSHH assessor for the unit.
Colin has a degree in Biochemistry and has worked in laboratories in various scientific sectors. Since 2002 he has worked in the pharmaceutical, R&D and virology industries. He joined the CRF in his current role in 2015.
Research Project Co-ordinator
Christie is the Project Co-ordinator at the Clinical Research Facility. Her role involves working closely with the Operational Support Manager and research nurses to safely and effectively schedule research activity of early phase and academic studies on the unit. Responsibilities include supporting study teams with the CRU application process and protocol review to create study specific documentation.
Christie has a degree in Biomedical Sciences (Physiology and Pharmacology) and joined the CRF as a Senior Data Officer in April 2016. Christie was appointed to her current position in April 2018.
Senior Data Officer
Stephen is a Band 4 Senior Data Officer on the Clinical Research Facility. His role involves working closely with Clinical Staff and Sponsors with the set-up of data requirements for clinical trials conducted on the CRF, ensuring any documents are fit for purpose with respect to capturing data, and entering data from paper sources into electronic databases within agreed turnaround times. Stephen is the main point of contact within the CRF for resolving data queries and ensuring that these are responded to in a timely manner, in addition to quality control of data entered onto databases. Stephen is also the Fire Warden for the unit.
Stephen started working in the NHS in 2013, initially working as a clerical officer within the Medical Records Department. In 2015 he began working as a Research Assistant on the Clinical Research Facility where he developed his knowledge and experience of Clinical Trials. He was appointed to his current position in April 2016.
Senior Data Officer
Jack works as a Senior Data Officer for the CRF. Jack is responsible for entering data onto study databases, quality controlling data, and liaising with the study team in order to ensure that the data collected on research studies is as accurate as it possibly can be.
Previously, Jack worked as a Clerical Research Assistant on the CRF- supporting the team with administrative duties, booking study appointments, and answering our general phone.
Quality Assurance Manager
David is the QA manager for RD&I and the CRF. His main role is to conduct audits against the Units SOPS and Processes. David also conducts study specific audits, maintains the Audit and Deviation Tracker and hosts external inspections.
David has a degree in Economics from London University.
Previously David worked in clinical governance and clinical audit both in primary and secondary care, taking a lead role in implementing the Quality and Outcomes Framework of the GMS 2 contract across GP surgeries in St Helens and latterly investigation of complaints against primary care doctors and dentists in Liverpool.