Assist site in problem solving and issue resolution as required throughout the studyTrain and re-train new research personnel, including Study Coordinators, Investigators, and site pharmacistsPerform site close-out visits to complete closeout tasks including test article reconciliation and disposition, review of accuracy and completeness of study files, retrieval of all outstanding documents and return of all study equipment Work closely with team members to ensure timely resolution of issues and obtain direction from CTL and managementProficient in multiple, different Electronic Data Capture and report writing systemsDevelop project specific tools and documents, such as protocol deviation and adverse event databases and reportsGather and maintain documentation for site specific files in accordance with FDA regulations and company SOP’sMonitor drug inventory, dispensing, compliance and returnTrack and report site enrollment, progress and adverse eventsEnsure that regulatory documents are complete and compliant with federal and internal guidelinesAssure Investigator and site adherence to timelines and GCP guidelinesPrepare and submit trip reports, expense reports and timesheets in a timely manner

Responsible for monitoring investigational sites to ensure that investigators and site personnel are meeting their obligations and are compliant with protocol, applicable local regulatory requirements and ICH GCP guidelines Facilitate Investigator site identification process and perform site evaluation visits to ensure that investigational sites are suitable and capable of conducting the prospective studyFacilitate site start up activities including budget negotiation, contract development and negotiations, site initiation visits and GCP instruction to Investigators/Research PersonnelFacilitate the setting up of new research sites and guided sites on submission of regulatory documents Provide clinical trial and protocol training during SIVs and participate in site training during Investigator meetingsPerform ongoing monitor visits to conduct source data verification, drug accountability, query generation and resolution, SAE verification and reporting oversight, regulatory file review and oversight, document submission for central archiving, monitor reports, general site support and communicationEnsure SAEs are promptly reported to the IRB and that affected subjects are given adequate medical care where applicablePrepare and submit trip reports, expense reports and timesheets in a timely manner

Managed and oversaw the operational process of in house studies to ensure that the trials were conducted in accordance with SOPs, regulatory standards and best practices, within approved timelines, resources and budgetsmanaging the operational aspects of projects to meet contractual; ensuring delivery of study quality and patient recruitment; driving site compliance; and leading, mentoring and training of the clinical operations teamManaged about 4 study coordinators and 2 data entry employees, and organized ongoing training for study teamsReported protocol deviations to sponsors and IRB Assisted the PM team with preparing study newsletters, website, and advertising campaigns Ensured all GCP/regulatory documentation was complete (filed in the Investigator File) Worked closely with CRAs, CRCs and CRNs and responded to monitoring/audit reports and protocol duties as neededDeveloped tools to assist coordinators with recruitment and data entry including an ICF script, FAQ slide presentation for EDC entry, and source documents

Support clinical research associates on a day to day basisSchedule PSSV’s, SIV’s, IMV’s and COV’s for CRA’sDraft CL, FUL and action item memos for CRA’s