Andrzej Jamkowy
Warsaw,Poland
Summary
A professional individual who quickly acquires technical knowledge and is open to sharing expertise with the team. Flexible, with a proactive attitude towards mastering new skills and knowledge, the professional easily adapts to new requirements and focuses on delivering the highest quality service.
Overview
9
9
years of professional experience
5
5
years of post-secondary education
Work history
Senior Clinical Research Associate
Worldwide Clinical Trials
Warsaw, Mazovia
10.2022 - Current
- Perform feasibility studies for potential sites, as requested.
- Conduct pre-study, study initiation, and interim monitoring visits in adherence to the protocol requirements.
- Function in the role of Lead CRA for global studies, coordinating CRAs.
- Develop Clinical Monitoring Plan as requested.
- Conduct site visit trip report review, and provide feedback and edits.
- Provide mentoring and guidance to less experienced CRAs and site staff, when needed.
- Design study-specific tools and templates, as requested.
- Actively participate in study team and investigator meetings.
- Actively participate in bid defences.
- Create and conduct training for study team members or colleagues as requested and appropriate.
- Work with Project Management to evaluate deliverables, and study milestones.
- Compile and ensure completeness of regulatory documents and ethical submission documentation, as appropriate and required (e.g. clinical trial applications). IRB / IEC study approval, informed consent, etc.
- Coordinate study material (e.g. CRFs, manuals, shipment, and receipt by study site).
- Document site visit findings via written reports.
- Provide input into the design of protocols and CRFs, as requested.
- Assess, monitor, and train study site staff on protocol adherence as required.
- Review study subject safety information, and informed consent.
- Conduct source document verification for compliance, patient safety, and veracity of data.
- Review CRFs using paper or electronic data capture systems, and assist sites with data query resolution.
- Assist the site in maintenance of the Investigator Site File.
- Maintain regular communication with sites.
- Provide applicable updates for site-related documentation for filing in the Trial Master File (TMF).
- Ensure site compliance with IP receipt, accountability, and return or destruction.
- Conduct accompanied site visits for assessment or training of other CRAs, as requested and appropriate.
- Complete final site close-out visit and report.
Senior Clinical Research Associate
KCR S.A outsourced to Servier
10.2021 - 09.2022
- Responsible for all aspects of study site monitoring including pre-study and initiation visits, routine monitoring, close-out visits and continuous maintenance of Investigator/Site Files
- Ensures that the study staff who will conduct the protocol have received proper materials and instructions to safely enter patients into the study
- Ensures the protection of study patients by verifying that informed consent procedures and protocol requirements are performed according to the applicable regulatory requirements
- Ensures the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
- Monitors data for missing or implausible data
- Ensures the resources of the Sponsor and company are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to travel policy
- Ensures implementation of all other assigned responsibilities/activities described in Project Monitoring Plans, Project Communication plans and other project-specific documents
- Ensures that all issues, deviations and violations are escalated to Project Manager/Project Lead
- Supervises Serious Adverse Event (SAE) reporting process on all stages, including preparation of the report and follow up of SAEs in assigned sites
- Performs CRF review; query generation and resolution against established data review guidelines on company or client data management systems in assigned studies
- Undertakes feasibility work when assigned by Line Manager
- Maintains quality control of assigned parts of Trial Master File (incl
- Site-related documentation)
- Assists with training and development of new employees, performs co-monitoring visits, provides training, provides assistance in monitoring in other sites including other countries of KCR if assigned by Line Manager
- Acts as a deputy for Clinical Project Manager in delegated tasks such as: co-monitoring visits, meetings during sponsor’s audits, budget preparation, feasibility projects, other special assignments if required
- Participating in internal and external Sponsor’s audits, local regulatory authorities inspection.
Clinical Research Associate II
KCR S.A outsourced to Servier
02.2020 - 09.2021
- Performing site pre-initiation, initiation, monitoring and close-out visits in accordance with Good Clinical Practice (GCP), relevant Standard Operating Procedures (SOPs) and local laws
- Conducting thorough protocol related training to the study investigational teams during study initiation and execution
- Liaising with Investigational team members, vendor and Sponsor representatives in order to manage ongoing projects’ expectations and issues, establishing effective communication lines with multiple parties
- Providing ongoing support to Investigators during Patients’ recruitment process, to ensure timely execution of assigned projects
- Managing and maintaining Investigator files, ensuring their completeness and accordance with GCP, relevant SOPs and local laws
- Oversight of Serious Adverse Events reporting process, ensuring Adverse Events are reported appropriately, accurately and in a timely manner and those follow-up activities are performed as necessary and in adherence to relevant laws, GCP and protocol
- Preparing translations and back translations of study documents
- Supporting organization of Investigators Meeting(s), including subject matter materials development and active participation during its conduct (as a speaker/trainer)
- Participating in internal and external Sponsor’s audits, local regulatory authorities inspection.
Clinical Research Associate I
KCR S.A outsourced to Servier
10.2018 - 01.2020
- Performing site pre-initiation, initiation, monitoring and close-out visits in accordance with Good Clinical Practice (GCP), relevant Standard Operating Procedures (SOPs) and local laws
- Conducting thorough protocol related training to the study investigational teams during study initiation and execution
- Liaising with Investigational team members, vendor and Sponsor representatives in order to manage ongoing projects’ expectations and issues, establishing effective communication lines with multiple parties
- Providing ongoing support to Investigators during Patients’ recruitment process, to ensure timely execution of assigned projects
- Managing and maintaining Investigator files, ensuring their completeness and accordance with GCP, relevant SOPs and local laws
- Oversight of Serious Adverse Events reporting process, ensuring Adverse Events are reported appropriately, accurately and in a timely manner and those follow-up activities are performed as necessary and in adherence to relevant laws, GCP and protocol
- Preparing translations and back translations of study documents
- Supporting organization of Investigators Meeting(s), including subject matter materials development and active participation during its conduct (as a speaker/trainer)
- Participating in internal and external Sponsor’s audits, local regulatory authorities inspection.
Clinical Trial Administrator II
KCR S.A. outsourced to Servier
04.2018 - 09.2018
- Prepared study registration files under supervision of COPM
- Prepared and was responsible for all assigned Trial Master Files
- Participated in preparation of administrative aspects of Investigator Meetings
- Ensured that the site staff who conducted the clinical trial had received proper documentation, supplies, materials and instructions within the established deadlines
- Timely forwarded all appropriate information to the investigators
- Collaborated with Clinical Research Associates, Clinical Project Leaders and Clinical Project Managers in the scope of assigned activities and projects
- Collaborated with investigators (correspondence, telephone) in all issues in the scope of assigned responsibilities and assigned projects
- Prepared completed studies for archiving, including the complete set of study correspondence on CD or in hard copies
- Regularly performed quality control of assigned TMF parts: checked study documentation at files, informed TMF section owners about missing documentation or other deficiencies and prepared administrative notes to file in the scope of assigned responsibilities and assigned projects.
Clinical Trial Administrator I
KCR S.A. outsourced to Servier
02.2017 - 03.2018
- Provided coordination and support to local and international study team across 5 countries during conduct 2 studies in 2 therapeutic areas
- Prepared, tracked and managed essential study documentation ensuring its accurateness and completeness in accordance with Good Clinical Practice (GCP)
- Prepared and distributed study-related materials and documentation amongst internal Team members
- Provided administrative support during study follow-up
- Actively supported the preparation of submission packages to Ethics Committees and Regulatory Authorities, following local regulations
- Directly communicated with Investigational Sites in the scope of assigned administrative tasks, including study-related documentation and materials ordering and distribution.
Junior Assistant
Alab Plus
10.2016 - 01.2017
- Initial quality control of histopathological material
- Initial preparation of biopsy material for the study
- Performed of a macroscopic description of histopathological material
- Performed other duties assigned by the Laboratory Coordinator.
Intern
University of Malaga, Spain
07.2016 - 09.2016
- Analysed some regulatory molecules by qRT-PCR in glioma cells
- Manipulation of the cancer cells culture
- Participated in manipulation and analysis some of the proteins in vitro.
Laboratory Coordinator's Assistant
BioVirtus Research Site
05.2016 - 07.2016
- Prepared materials and laboratory equipment to the study assigned by Laboratory Coordinator
- Processed biofluids and preparation to the shipping to an external laboratory
- Filled out of the laboratory documentation assigned by Laboratory Coordinator
- Prepared the documentation for participants
- Performed other duties assigned by the Laboratory Coordinator.
Intern
Institute of Organic Chemistry and Biochemistry Czech Academy of Science, Prague, Chech Republic
08.2015 - 10.2015
- Prepared DNA for expressing single cysteine mutants of α-Synuclein (αSyn)
- Expression of recombinant αSyn mutants in bacteria and their purification
- Labelling of proteins with fluorescent probes
- Measurements of fluorescence response upon binding of labelled αSyn to membranes.
Education
MSc - Molecular Biotechnology
University of Warsaw
10.2014 - 06.2017
BSc - Biotechnology
University of Lodz
10.2011 - 06.2014
Languages
English - business working level
Fluent
Polish - business working level
Fluent
Russian - business working level
Fluent
Ukrainian
Native
Custom
I hereby give consent for my personal data included in my application to be processed for the purposes of the recruitment process under the European Parliament's and Council of the European Union Regulation on the Protection of Natural Persons as of 27 April 2016, with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (Data Protection Directive).
Timeline
Senior Clinical Research Associate
Worldwide Clinical Trials
10.2022 - Current
Senior Clinical Research Associate
KCR S.A outsourced to Servier
10.2021 - 09.2022
Clinical Research Associate II
KCR S.A outsourced to Servier
02.2020 - 09.2021
Clinical Research Associate I
KCR S.A outsourced to Servier
10.2018 - 01.2020
Clinical Trial Administrator II
KCR S.A. outsourced to Servier
04.2018 - 09.2018
Clinical Trial Administrator I
KCR S.A. outsourced to Servier
02.2017 - 03.2018
Junior Assistant
Alab Plus
10.2016 - 01.2017
Intern
University of Malaga, Spain
07.2016 - 09.2016
Laboratory Coordinator's Assistant
BioVirtus Research Site
05.2016 - 07.2016
Intern
Institute of Organic Chemistry and Biochemistry Czech Academy of Science, Prague, Chech Republic
08.2015 - 10.2015
MSc - Molecular Biotechnology
University of Warsaw
10.2014 - 06.2017
BSc - Biotechnology
University of Lodz
10.2011 - 06.2014
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