Reka Drotosne Szatmari
Birmingham,United Kingdom
Summary
Accomplished professional with expertise in clinical trial methodology and compliance, specializing in GCP. Proven ability to drive project success through meticulous planning and monitoring, ensuring adherence to regulatory standards. Strong analytical skills and effective communication facilitate collaboration among cross-functional teams.
Overview
14
14
years of professional experience
2027
2027
years of post-secondary education
Work history
Clinical Research Associate
Novo Nordisk
Birmingham
12.2023 - Current
- Coordinated clinical trial activities, ensuring ongoing inspection readiness and adherence to protocols.
- Conducted site monitoring visits to verify constant adherence to Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Detected protocol deviations, using appropriate channels to report and escalate incidents.
- Executed comprehensive Case Report Form (CRF) reviews and verified source documents.
- Monitored patient recruitment, optimising enrolment and retention rates.
- Collaborated with cross-functional teams to develop study protocols and materials.
- Reviewed clinical data for accuracy, ensuring report integrity.
- Managed external stakeholder relationships to enhance collaboration and communication.
- Implemented process improvements, streamlining operations and increasing efficiency.
- Conducted site selection visits, confirming appropriate investigator selection and timely documentation.
- Facilitated Site Initiation Visits for staff on trial procedures and documentation.
Operations Officer
HTRC, High Temperature Research Centre, Ansty Business Park, Rolls - Royce
Coventry, West Midlands
08.2021 - 11.2023
- Conducted ISO 9001:2015 internal audits to ensure compliance and drive quality improvements.
- Coordinated training courses to support ongoing staff development and skill enhancement.
- Managed legal non-disclosure agreement register and applications for organisational compliance.
- Delivered centre inductions for permanent and associate staff, promoting seamless onboarding.
- Promoted efficient workflow by verifying policy distribution, understanding, and adherence.
- Assessed DSE compliance as an assessor and first aid coordinator, ensuring workplace safety.
- Collaborated with management team to drive continuous improvement and foster innovation.
Project Officer
NIHR NAFLD BioResource-University Hospital Birmingham NHS
Birmingham, West Midlands
12.2019 - 08.2021
- Served as primary communication liaison for NIHR-funded NAFLD BioResource research.
- Distributed project documentation to relevant stakeholders for efficient information flow.
- Managed user access rights for NAFLD Project Database and oversaw patient data management.
- Monitored project status, ensuring adherence to budget and timelines.
- Handled sensitive data to generate compliance reports for local and NIHR requirements.
- Simultaneously managed multiple engagements, balancing diverse stakeholder needs.
- Selected appropriate sites and investigators, establishing recruitment centres nationwide.
- Executed clinical tasks including phlebotomy, sample handling, and processing.
Project Assistant/Data Manager
Liver Research- University Hospital Birmingham NHS
Birmingham, West Midlands
01.2019 - 12.2019
- Produced project work schedules to enhance operational efficiency.
- Established and maintained study CTMF for streamlined processes.
- Created databases and spreadsheets to optimise inventory management and reporting accuracy.
- Supported site monitoring visits, resolving data queries and site issues promptly.
- Cultivated relationships with staff and key stakeholders using effective communication strategies.
- Analysed data for presentation to the Research & Development Team.
- Reviewed expense reports and invoices to facilitate monthly accounting processes.
- Managed stock, ensuring clinical kits remained current and compliant.
Medical Laboratory Admin Assistant
Blood Transfusion - University Hospital Birmingham NHS
Birmingham, West Midlands
01.2018 - 01.2019
- Delivered comprehensive administrative support services for BTS department.
- Maintained files and documents, overseeing training spreadsheet management.
- Communicated with Quality Control Manager to establish QA schedule for BTS centres.
- Completed National Comparative Audit for O Neg blood with precision.
- Produced reports detailing project progress and outcomes.
- Sent reports, letters, and requisitions to relevant departments and stakeholders efficiently.
- Executed duties to achieve targets with accuracy and efficiency.
Research Assistant
HIV Research - University Hospital Birmingham NHS
Birmingham, West Midlands
04.2016 - 01.2018
- Developed interview questions and recruited participants to optimise response quality.
- Maintained essential documents for study site staff, ensuring compliance and currency.
- Managed daily office administration tasks to support research operations.
- Entered serious adverse events and patient information into electronic case report forms for various studies.
- Provided updated databases to relevant sites while presenting milestones biannually to the HIV team.
- Liaised with external agencies, sending study-related documents to clinical research associates regularly.
- Monitored new and revised protocols within the research department to maintain adherence.
- Set up, calibrated, and maintained field or laboratory equipment in accordance with study specifications.
Support Nurse
Whittall Street Genitourinary Medicine GUM Clinic
Birmingham, West Midlands
02.2013 - 04.2016
- Organised various teaching and training activities to enhance team skills.
- Provided administrative support to GUM Research team, ensuring operational efficiency.
- Assisted at special clinics, including implant, coil, biopsy, and dermatology.
- Handled specimens with care, maintaining privacy and dignity throughout processes.
- Processed test results accurately to facilitate timely patient management.
- Collaborated with clinical team to implement prescribed treatments tailored to patient needs.
Auxiliary Nurse
Whittall Street Genitourinary Medicine GUM Clinic
Birmingham, West Midlands
04.2012 - 02.2013
- Facilitated identification of training needs for assistants by qualified practitioners.
- Executed safe manual handling to enhance patient independence during mobility assistance.
- Entered patient data into clinical systems in compliance with confidentiality regulations.
- Prepared treatment rooms for efficient use and optimal patient care.
- Monitored medical supply levels and restocked examination rooms as necessary.
Education
Good Clinical Practice (GCP) - Clinical Practice
NIHR
UKResearch Methods for Clinical Trials - Clinical Research
University of Birmingham
Birmingham, BIRBachelor's degree - District Nursing
University of Debrecen
Hungary 09.2004 - 06.2008
ISO 9001:2015 Internal Auditor - Quality Management
NQA
UKSkills
- Clinical trial methodology and compliance
- Good clinical practice (GCP) and good laboratory practice (GLP)
- Quality management systems
- Study protocol development
- Interim monitoring and site visits
- Clinical trial recruitment strategies
- Electronic clinical trials and IT systems
- Project management and multi-site coordination
- Data collection and analysis
- Risk assessment and operational expertise
- Investigator relationship management
- Adverse event reporting and site selection
- Trial oversight
- Database lock activities
- Monitoring capabilities
- Clinical study report creation
- Site initiation visit execution
- Risk-based monitoring techniques
LANGUAGES
English - Fluent
Hungarian - Native
Timeline
Clinical Research Associate
Novo Nordisk
12.2023 - Current
Operations Officer
HTRC, High Temperature Research Centre, Ansty Business Park, Rolls - Royce
08.2021 - 11.2023
Project Officer
NIHR NAFLD BioResource-University Hospital Birmingham NHS
12.2019 - 08.2021
Project Assistant/Data Manager
Liver Research- University Hospital Birmingham NHS
01.2019 - 12.2019
Medical Laboratory Admin Assistant
Blood Transfusion - University Hospital Birmingham NHS
01.2018 - 01.2019
Research Assistant
HIV Research - University Hospital Birmingham NHS
04.2016 - 01.2018
Support Nurse
Whittall Street Genitourinary Medicine GUM Clinic
02.2013 - 04.2016
Auxiliary Nurse
Whittall Street Genitourinary Medicine GUM Clinic
04.2012 - 02.2013
Bachelor's degree - District Nursing
University of Debrecen
09.2004 - 06.2008
Good Clinical Practice (GCP) - Clinical Practice
NIHR
Research Methods for Clinical Trials - Clinical Research
University of Birmingham
ISO 9001:2015 Internal Auditor - Quality Management
NQA