Klara Somlai Dr. Hacklerné
Szeged
Summary
Diligent in Clinical Research area with comprehensive background in coordinating clinical research studies. Successfully managed multiple clinical trials from initiation to closeout, ensuring adherence to regulatory guidelines. Demonstrated ability to effectively communicate with cross-functional teams and maintain meticulous documentation.
Overview
19
19
years of professional experience
Work History
Clinical Reseach Coordinator
Univ.of Szeged, Dp. of Rheumatology and Immunology
12.2023 - Current
- Follow clinical research protocols and conduct study visits in compliance with ICH/GCP and FDA regulations.
- After identifying prospective candidates for research studies our site screens/randomizes patients and carries out numerous study and follow up visits.
- Work with principal investigators/sub-investigators, lab technicians, nurses and sponsors to facilitate daily trial activities and comply with research protocols.
- Enhance patient safety by meticulously monitoring and documenting adverse events during clinical trials.
Certified Public Accountant
Private Accounting & Bookkeeping Services
11.2021 - 12.2023
- Advised clients on tax planning strategies, helping them minimize liabilities while adhering to tax laws and regulations.
- Setup accounts, ledgers and reporting systems per GAAP standards and regulatory requirements.
- Used accounting software to issue tax returns and prepare consolidated reports.
- Cooperated with senior leaders to create operating budgets and initiate financial planning.
Back Office Manager
HCEMM-Hungarian Center of Excellence for Molecular
08.2020 - 11.2020
- Coordinated the timely and accurate filing of all necessary documentation for legal, regulatory, and tax purposes.
- Coordinated office events, seminars and meetings for staff and clients.
- Ordered office supplies and maintained supplier contacts in database.
Clinical Reseach Coordinator
Univ.of Szeged, Dept. of Ophthalmology
12.2011 - 07.2020
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Gathered, processed, and shipped lab specimens.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Enhanced patient safety by monitoring and documenting adverse events during clinical trials.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Trained new team members on essential clinical research protocols and procedures.
- Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
Budget Specialist
Johns Hopkins University, Wilmer Eye Inst.
04.2006 - 08.2010
- Managed, coordinated and prioritized multiple tasks and complex reporting assignments.
- Assisted foreign PhD students in initiating their workspaces.
- Ensured timely ordering of laboratory materials.
- Contributed to grant proposal writing efforts required for funding applications.
Education
Certified Public Accountant -
Hungarian Chamber of Auditors Education Center
Budapest, Hungary03-2022
Master of Economics - European Integration And World Economic Adjustment
Corvinus University of Budapest
07-2004
Skills
- Good clinical practices
- Electronic data capture
- Documentation management
- Adverse event reporting
- Research experience
- Clinical trial management
- Time management
- Problem-solving
- Teamwork and collaboration
- Multitasking Abilities
- Organizational skills
- Analytical skills
Languages
Hungarian
Native language
English
Advanced
C1
Italian
Elementary
A2
Timeline
Clinical Reseach Coordinator
Univ.of Szeged, Dp. of Rheumatology and Immunology
12.2023 - Current
Certified Public Accountant
Private Accounting & Bookkeeping Services
11.2021 - 12.2023
Back Office Manager
HCEMM-Hungarian Center of Excellence for Molecular
08.2020 - 11.2020
Clinical Reseach Coordinator
Univ.of Szeged, Dept. of Ophthalmology
12.2011 - 07.2020
Budget Specialist
Johns Hopkins University, Wilmer Eye Inst.
04.2006 - 08.2010
Certified Public Accountant -
Hungarian Chamber of Auditors Education Center
Master of Economics - European Integration And World Economic Adjustment
Corvinus University of Budapest
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