Farkas Kolozsi
Budapest,Hungary
Summary
Sr CRA II with extensive experience in clinical research and regulatory compliance. Proficient in monitoring clinical trials, ensuring adherence to protocols, and managing data quality to support successful study outcomes. Committed to advancing clinical development through rigorous oversight and process optimization. Detail-oriented professional with expertise in compliance, quality assurance, and problem-solving. Adept at ensuring adherence to regulations and delivering solutions that enhance operational efficiency.
Reliable CRA with keen eye for identifying and resolving site issues, coupled with strong problem-solving and communication skills. Proficient in ensuring safety compliance and coordinating with various stakeholders to maintain smooth project operations. Capable of significantly enhancing site efficiency and safety standards through meticulous monitoring and proactive interventions.
Driven to deliver high-quality service and consistent results, leading to better project outcomes and team performance.
Overview
16
16
years of professional experience
5
5
years of post-secondary education
Work history
Sr CRA II on assignment as Sanofi Site Monitor
Syneos Health
Budapest, Hungary
2025.03 - Current
Completes project activities associated with monitoring functions of Phase I-IV clinical research studies while developing mastery and a thorough understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations.
Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures.
Senior CRA II
Syneos Health
, Hungary
2017.04 - 2025.03
Completes project activities associated with monitoring functions of Phase I-IV clinical research studies while developing mastery and a thorough understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations.
Provides clinical and technical support for Clinical Research Associates (CRA) I, II, III and administrative staff.
Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures.
Senior CRA
INC Research
2015.04 - 2017.04
Completes project activities associated with monitoring functions of Phase I-IV clinical research studies while developing mastery and a thorough understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations.
Provides clinical and technical support for Clinical Research Associates (CRA) I, II, III and administrative staff.
Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures.
CRA III
INC Research
2013.07 - 2015.03
Completes project activities associated with monitoring functions of Phase I-IV clinical research studies while developing mastery and a thorough understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations.
Provides clinical and technical support for Clinical Research Associates (CRA) I and II and administrative staff.
Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures.
Regulatory Specialist
KCR S.A.
2012.07 - 2013.07
Cooperation with Sponsors, CRM/CRA/CTA in the scope of national trial registration: preparing documentation for new study application and updates.
Cooperation with Legal Department Specialists in the scope of trial registration and study updates.
Performing complete verification of all study application files before submission to National Regulatory Authorities Committee
Informing the General Manager of any problems arising during the cooperation with local Competent Authority, Ethics Committee and Sponsors.
Senior Clinical Research Associate
KCR S.A.
2012.04 - 2013.07
Monitoring studies; types of visits: pre-study, initiation, monitoring, close-out
Performing feasibilities
Participating in process of training and development of new employees
Acting as a deputy for Clinical Research Manager for assigned tasks
Participating in Sponsor Audits
Clinical Research Associate
KCR S.A.
2011.10 - 2012.04
Monitored studies; types of visits performed: pre-study, initiation, monitoring, close-out
Performed feasibilities
Participated in process of training and development of new employees
Participated in Sponsor Audits
Clinical Research Associate
M.E. Trial Masters Hungary
, Hungary
2010.02 - 2011.08
Participated in feasibility process
Monitored studies; types of visits performed: pre-study, initiation, monitoring, close-out
Participated in site audit, performed by sponsor
Prepared submissions to RA/EC
Prepared financial contracts
Education
Masters - Medicine
Medical University Sofia
1996.09 - 2002.02
Skills
Compliance; Problem-solving; Good communication skills; Quality Assurance
LANGUAGES
English
Fluent
Bulgarian
Native
Hungarian
Native
THERAPEUTIC EXPERIENCE
- THERAPEUTIC AREA: Cardiovascular
- INDICATION: Generalized CVD
- SUB-INDICATION: General cardiovascular indications
- MESH: Chronic Limb-Threatening Ischemia
- INDICATION: Peripheral vascular disorders
- SUB-INDICATION: Varicose veins
- MESH: Varicose Veins
- THERAPEUTIC AREA: Dermatology
- INDICATION: Dermatoses
- SUB-INDICATION: Eczema/Dermatitis
- MESH: Atopic Dermatitis
- INDICATION: Skin disorders
- SUB-INDICATION: Pruritus
- MESH: Pruritus
- THERAPEUTIC AREA: Endocrinology/Metabolism
- INDICATION: Diabetes treatment
- SUB-INDICATION: Diabetes, type 1
- MESH: Diabetes, type 1
- INDICATION: Glomerular disorders
- SUB-INDICATION: Diabetic nephropathy
- MESH: Not Available
- THERAPEUTIC AREA: Gastroenterology
- INDICATION: Inflammatory bowel disease (IBD)
- SUB-INDICATION: Crohn's disease
- MESH: Crohn's disease
- THERAPEUTIC AREA: Hematology
- INDICATION: Blood cell disorders
- SUB-INDICATION: Anemia, other
- MESH: Anemia, other
- THERAPEUTIC AREA: Hepatology
- INDICATION: Biliary disorders
- SUB-INDICATION: General biliary disorders
- MESH: Metabolic dysfunction-associated steatohepatitis (MASH)
- INDICATION: Hepatic disorders
- SUB-INDICATION: Metabolic dysfunction-associated steatohepatitis (MASH)
- THERAPEUTIC AREA: Immunology
- INDICATION: Autoimmune disorders
- SUB-INDICATION: Systemic lupus erythematosus (SLE)
- MESH: Systemic Lupus Erythematosus
- INDICATION: Rheumatology
- SUB-INDICATION: Arthritis, rheumatoid
- MESH: Rheumatoid Arthritis
- THERAPEUTIC AREA: Infectious Disease
- INDICATION: Bacterial infections
- THERAPEUTIC AREA: Nephrology
- SUB-INDICATION: Focal segmental glomerulosclerosis (FSGS)
- THERAPEUTIC AREA: Neurology
- INDICATION: Stroke
- SUB-INDICATION: Stroke, acute
- MESH: Acute Ischemic Stroke
- THERAPEUTIC AREA: Oncology
- INDICATION: Solid tumors
- SUB-INDICATION: Prostate cancer
- MESH: Gastrointestinal Cancers
- SUB-INDICATION: Solid tumor indications
- THERAPEUTIC AREA: Respiratory
- INDICATION: Chronic obstructive airways disease
- SUB-INDICATION: COAD/COPD
- MESH: COAD/COPD
Timeline
Sr CRA II on assignment as Sanofi Site Monitor
Syneos Health
2025.03 - Current
Senior CRA II
Syneos Health
2017.04 - 2025.03
Senior CRA
INC Research
2015.04 - 2017.04
CRA III
INC Research
2013.07 - 2015.03
Regulatory Specialist
KCR S.A.
2012.07 - 2013.07
Senior Clinical Research Associate
KCR S.A.
2012.04 - 2013.07
Clinical Research Associate
KCR S.A.
2011.10 - 2012.04
Clinical Research Associate
M.E. Trial Masters Hungary
2010.02 - 2011.08
Masters - Medicine
Medical University Sofia
1996.09 - 2002.02