Experience

Clinscience

• Poland
• Research Services
• 100 - 200 Employee

• PM/ SCRA

  • Aug 2020 - Present

  Experienced Clinical Research Professional with over 15 years history of successful monitoring and management of clinical studies. Collaborative, innovative, and solutions-oriented industry expert with wide experience in feasibility, contracts negotiation, vendors management, project management, regulatory submissions, monitoring and focused on completing clinical trials within timelines and budgets. Motivational to other team members and colleagues involved in training programs and SOPs development. Show less



COMAC MEDICAL

• Bulgaria
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• SCRA/ Lead CRA

  • Mar 2019 - Jul 2020

  Perform feasibility studies for potential sites as requested • Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements • Perform Regulatory and/ or EC submissions for Poland (also for device) • 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 • Create and conduct training to 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. 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 Show less



Own company

• Warsaw, Mazowieckie, Poland

• Freelance SCRA

  • Nov 2018 - Mar 2019

  Perform feasibility studies for potential sites as requested • Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements • Perform Regulatory and/ or EC submissions for Poland • 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 • Create and conduct training to 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. 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 Show less



WORLDWIDE CLINICAL TRIALS

• Warsaw Area, Poland

• SCRA

  • Apr 2012 - Nov 2018

  • Perform feasibility studies for potential sites as requested • Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements • Perform Regulatory and/ or EC submissions for Poland (also for device) • 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 • Create and conduct training to 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. 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 Show less



KCR

• United States
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• CRA

  • Jan 2008 - Apr 2012

  ‣ Conducting pre-study and study initiation visits with clients and reporting findings. ‣ Ensuring completeness and accuracy of the documentation. ‣ Coordination of study material, e.g. CRFs Clinical Trial Material (CTM) shipment and receipt by study site. ‣ Maintenance of Investigator Site File. ‣ Conducting monitoring to include Source Document Verification (SDV), site file maintenance and CTM accountability. ‣ Mentoring and coaching of other Clinical Research Associates. Preparing concise reports of monitoring visits. ‣ Conducting ongoing oral and written communications with study site. ‣ Demonstrating efficacies in CTMs, Microsoft Office, IVRS, and eCRF packages. ‣ Providing all site-related study documentation for the Trial Master File (TMF). ‣ Completion of CRF reviews. ‣ Providing query resolution. ‣ Maintaining close-out activities in compliance with regulatory requirements Show less



Hesperion/Averion

• Clinical Research Associate

  • Apr 2006 - Jan 2008

  ‣ Monitoring of clinical trials (on-site monitoring and in-house job in Poland and Czech Republic) ‣ Perform Regulatory and/ or EC submissions for Polan ‣ Conducting pre-study and study initiation visits with clients and reporting findings. ‣ Ensuring completeness and accuracy of the documentation. ‣ Coordination of study material, e.g. CRFs Clinical Trial Material (CTM) shipment and receipt by study site. ‣ Maintenance of Investigator Site File. ‣ Assessment, monitoring and training staff for protocol adherence. ‣ Conducting monitoring to include Source Document Verification (SDV), site file maintenance and CTM accountability. ‣ Conducting ongoing oral and written communications with study site. ‣ Demonstrating efficacies in CTMs, Microsoft Office, IVRS, and eCRF packages. ‣ Providing all site-related study documentation for the Trial Master File (TMF). ‣ Completion of CRF reviews. ‣ Providing query resolution. ‣ Completion of final study termination visit reports. ‣ Maintaining close-out activities in compliance with regulatory requirements Show less



Mercedes Benz

• Customer service Representative

  • May 2005 - Apr 2006

  CSR at Daimler Chrysler Customer Assistance Center for Poland, Hungary, Slovakia and Czech Republic CSR at Daimler Chrysler Customer Assistance Center for Poland, Hungary, Slovakia and Czech Republic