Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Generic

MARCIN KACZKOWSKI

Buczyna

Summary

I am a very experienced specialist (15 years) in clinical monitoring with strong educational background. Conducted trails fields: hematology, neurology, oncology, dermatology, psychiatry, ophthalmology, cardiology and vaccines. Visits types: feasibility, PSV, SIV, FU, COV, QC. Service at monitoring and conducting study on site, screening/randomization supervising, SAE review, medical documents translations, reports writing, RA/EC submissions and Internal Quality Audit. Moreover, support in site contract negotiation and management. Used databases: Oracle, InForm, Clintrial, IMPACT, RAVE, PHT, Almac, IRT endpoint, ERT, Labcorp, Eurofins, PPD, Trident, Excelsior, Clinical Ink, DrugDev, various CTMS and many other Vendor's portals.

Overview

15
15
years of professional experience
1
1
Certification

Work History

Freelance Sr CRA

Self-employed
09.2022 - Current
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.

Sr Clinical Research Associate

Syneos Health
Cracow
07.2014 - 09.2022
  • performing site feasibilities, site qualification visits, site initiation visits, interim monitoring visit (Phase I/II/III), close-out visits
  • independently and proactively coordinate the necessary activities required to set up and monitor a study,

Senior Clinical Research Associate

IQVIA, formerly Quintiles
Warsaw
07.2012 - 07.2014
  • performing site feasibilities, site qualification visits, site initiation visits, interim monitoring visit (Phase II/III), close-out visits
  • independently and proactively coordinate the necessary activities required to set up and monitor a study,

Clinical Research Associate

ERGOMED
Cracow
06.2011 - 07.2012
  • performing site feasibilities, site qualification visits, site initiation visits, interim monitoring visit (Phase II/III), close-out visits
  • independently and proactively coordinate the necessary activities required to set up and monitor a study,

Clinical Research Associate

Bioscience
Cracow
03.2009 - 06.2011
  • performing site feasibilities, site qualification visits, site initiation visits, interim monitoring visit (Phase I/II/III), close-out visits
  • independently and proactively coordinate the necessary activities required to set up and monitor a study
  • negotiation of contracts with Institutions and Investigators
  • preparation of documentation for RA/EC submissions

Research Team Member

TF Instruments GmbH
Heidelberg
10.2007 - 03.2008
  • Leonardo da Vinci research project within the framework of student exchange.

Education

Master of Science - Biophysics

Jagiellonian University
2008

Skills

  • Neurology - 10 years experience
  • Oncology - 5 years experience
  • Hematology - 5 years experience
  • Dermatology - 2 years experience
  • Gastroenterology - 1 year experience
  • Ophthalmology - 3 years experience
  • Psychiatry - 4 years experience
  • Diabetology - 1 year experience
  • Pulmonology - 1 year experience
  • Cardiology - 2 years experience
  • Infectious Disease - 2 years experience

Certification

Current ICH GCP E6 (R2) certification completed in Oct 2022.

Languages

Polish
Native language
English
Advanced
C1
German
Elementary
A2

Timeline

Freelance Sr CRA

Self-employed
09.2022 - Current

Sr Clinical Research Associate

Syneos Health
07.2014 - 09.2022

Senior Clinical Research Associate

IQVIA, formerly Quintiles
07.2012 - 07.2014

Clinical Research Associate

ERGOMED
06.2011 - 07.2012

Clinical Research Associate

Bioscience
03.2009 - 06.2011

Research Team Member

TF Instruments GmbH
10.2007 - 03.2008

Master of Science - Biophysics

Jagiellonian University

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