Kostyantyn Shchupachenko Email & Phone Number

Ukraine

• Accountable for multiple projects simultaneously• Lead core project team and facilitate their ability to lead extended/complete project team • Lead cross-unit coordination both internal and external, inclusive of sub-contractors• Define project resource needs and establish contingency plans for key resources • Ensure successful design, implementation, tracking and revision of project plans for assigned projects• Promote effective teamwork among project team members • Resolve conflicts as needed• Ensure appropriate communication on project-related matters with the PM Management • Meet financial performance targets for the assigned clinical projects• Ensure project deliverables are met according to both Worldwide and client expectations • Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects• Act as key client contact for assigned projects/clients• Establish excellent working relationships with client project teams and vendors to ensure client satisfaction and operational excellence• Ensure that all staff allocated to assigned projects adheres to professional standards and SOPs established for clinical research• Perform other duties as assigned by management

Ukraine

• Lead core project team and facilitate their ability to lead extended/complete project team• Lead cross-unit coordination both internal and external, inclusive of sub-contractors• Define and manage project resource needs and establish contingency plans for key resources• Ensure successful design, implementation, tracking, and revision of project plans for assigned projects• Promote effective teamwork among project team members Resolve conflicts as needed• Ensure appropriate communication on project-related matters with the PM Management• Meet financial performance targets for the assigned clinical projects• Ensure project deliverables are met according to both WCT and client expectations• Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects• Act as key client contact for assigned projects• Establish excellent working relationships with client project teams and vendors to ensure client satisfaction and operational excellence.• Ensure that all staff allocated to assigned projects adheres to professional standards and SOPs established for clinical research.• Manage all aspects of designated projects• Perform other duties as assigned by management.

Kyiv, Ukraine

• Lead core project team members and facilitate their ability to lead extended/complete project team• Lead cross unit coordination both internal and external, inclusive of sub-contractors • Define and manage project resource needs in conjunction with functional heads and establish contingency plans for key resources• Ensure successful design, implementation, tracking and revision of project plans for assigned projects• Promote effective teamwork among project team members; resolve conflicts as needed• Ensure appropriate communication on project-related matters with the PM Management• Meet financial performance targets for the assigned clinical projects • Ensure project deliverables are met according to both WCT and client expectations• Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects• Act as key client contact for assigned projects• Establish excellent working relationships with client project teams to ensure client satisfaction and operational excellence• Ensure that all staff allocated to assigned projects are trained on the study protocol and all other study related processes, adhere to professional standards and to SOPs as well as current Good Clinical Practice (GCP) and applicable local regulations• Liaise with functional line management in identification of any training or development needs and input into the performance appraisal process for trial team members• Manage delegated aspects of designated projects • Perform other duties as assigned by management • Perform other duties as assigned.

Kiev Region, Ukraine

• 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 defenses• 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

Kyiv, Ukraine

• 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 defenses• 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

Kiev

Perform feasibility studies as requestedConduct pre-study and study initiation visitsEnsure completeness, accuracy and submit regulatory and ethical submission documentation as appropriate.Coordinate study materials shipment and receipt by study siteAccurately maintain Investigator Site fileReport findings at pre-study and initiation visits in site visit reportAssess, monitor and train study site staff if required for protocol adherenceConduct monitoring to include Source document verification (SDV), site file maintenance and CTM accountability to a standard that allows mentoring and coaching of other CRAsFrequent and complete communications with study sitesGenerate written correspondence with study sitesPrepare concise reports of monitoring visitsDemonstrate efficacies in CTMS, Microsoft Office, IVRS, and eCRF packagesProvide all site related study documentation for filing into the TMFComplete CRF review, retrieve CRFs and transmit to appropriate person/personsDemonstrate competence in query resolutionComplete final study termination visit reportMaintain close-out activities in compliance with regulatory requirementsMaintain documentation of telephone communications

Kiev

Participate in pre-study and study initiation visits, as applicable and appropriateReport findings at pre-study and initiation visits in site visit report, as applicable and appropriateAssess and report on protocol adherence at study siteEnsure completeness and compile regulatory documentsEnsure proper storage of CTM and documentation of CTM accountabilityFrequent and complete communications with study sitesVerify adequate source documentationCheck CRFs for accuracy and completenessTransmit CRFs to appropriate personsComplete CRF review, retrieve CRFs and transmit to appropriate person/personsAccurately maintain Investigator Site fileProvide all site related study documentation for filing into the TMFMaintain documentation of telephone communicationsPrepare reports of monitoring visitsGenerate written correspondence with study sitesResolve data management queriesEnsure compliance with regulatory requirements for study filesEnsure compliance with regulatory requirements for CTM accountabilityComplete final study termination visit report

Kharkiv, Ukraine

IP/CTM handling.To carry out instruction of direct leadershipTo perform technical work with documents.To perform accountability of drug.To contact centers regarding supply issues.To take part in local purchases.To unpack and check contents and condition of incoming shipments.To perform quality control functions.To generate inventory list for the incoming shipments.To place incoming shipments in appropriate place at the storage area.To prepare outgoing shipments.To perform the inventory of study drug and study materials at the Depot.To perform re-labeling.To review temperature logsBio samples handlingTo coordinate local couriers service

Responsibilities Selling study medication, bandage materials, children's nourishment and cosmeticsConsultation for clientsUnpacking and checking contents and condition of incoming shipmentsPlacing incoming shipments in appropriate place in accordance with temperature conditionsPerforming the inventory of study medication and other additional materialsWorking with current documentation

ResponsibilitiesSelling study medication, bandage materials, children's nourishment and cosmeticsConsultation for clientsUnpacking and checking contents and condition of incoming shipmentsPlacing incoming shipments in appropriate place in accordance with temperature conditionsPerforming the inventory of study medication and other additional materialsWorking with current documentation

Magister, Pharmaceuticals

Specialist, Pharmaceuticals