• ThermoFisher-Nov2023-May2024• Parexel – Sep2022-Sep2023• Lotus CRO – May2022 –Aug2022• Worldwide Clinical Trials – Sep2021-Apr2022• Perform feasibility studies for potential sites.• Conduct pre-study, study initiation and interim monitoring visits in adherence tothe protocol requirements.• Function in the role of Lead CRA, 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.• 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• Work with Project Management to evaluate deliverables and study milestones• Compile and ensure completeness of regulatory documents and ethicalsubmission documentation as appropriate and required (e.g. IRB / IEC studyapproval, 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.• Assess, monitor, and train study site staff on protocol adherence.• Review study subject safety information and informed consent.• Conduct source document verification for compliance, patient safety, and veracityof data.• Review CRFs using paper or electronic data capture systems and assist sites withdata query resolution.• Assist the site in maintenance of the Investigator Site File.• Maintain regular communication with site staff.• Provide applicable updates for site related documentation for filing in the TrialMaster File (TMF).• Conduct accompanied site visits for assessment or training of CRAs.• Complete final site close out visit and report

•Conducted qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol;•Communicated with the medical site staff including coordinators, clinical research physicians and their site staff; •Verified adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; •Verified medical record and research source documentation against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements;•Verified that the investigator is enrolling only eligible subjects;•Reviewed regulatory documents;•Performed medical device and/or investigational product/drug accountability and inventory;•Verified and reviewed adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;•Assessed the clinical research site’s patient recruitment and retention success and offering suggestions for improvement;•Authored of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.