-Supervised aspects of global Phase III trial with accountability for meeting agreed timelines, budgets and performance quality.-Anticipated project requirements and proactively respond to ensure timelines are met.-Key contact with client regarding all clinical aspects of assigned protocol.-Managed follow-up of quality audit reports.-Participated and provided responses to mock-FDA and EMA audits.-Created and provided status reports regarding project activity.-Developed and implemented project plan(s) for assigned studies.-Interacted with internal departments and external vendors to evaluate needs, resources and timelines.-Ensure appropriate quality and timely monitoring of investigative sites by the project team.-Conduct investigators’ meetings.-Identify and create training development and recognition needs of project team.-Assist business development in proposal generation and undertake feasibility work when requested.-Perform other duties as assigned by management.

-Managed international clinical research operations in adult bone-marrow derived stem cell Phase II-III and compassionate use trials in vascular and bone indications. -Supported finance by estimating and forecasting trial budgets for each protocol including sites, vendors and clinical supplies. -Managed contracted CRO to ensure timelines, budget and monitoring responsibilities were met.-Key contact and responsible for vendor identification, budget negotiations, training and oversight. -Drafted, reviewed and provided logistical considerations for clinical protocols. -Managed the development of case report forms, clinical trial reports and other clinical documents, as required.-Summarized data from Aastrom sponsored trials and compassionate use trials for summary in IND submissions. -Responsible for creating and amending all clinical SOP’s and clinical templates. -Identified, contracted and monitored clinical sites.

-Managed trials the clinical research operations (Phase I-II) department in multiple therapeutic indications. -Led study workgroup teams in all aspects of study conduct including protocol development, investigator site selection, development of study plans, CRF development, study timeline tracking and reporting, and special equipment training. -Responsible for planning and conducting investigator meetings-Managed CRA resourcing and training. -Developed and negotiated site budgets.-Educated peers on trial specific processes and optimized processes.

-Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of stud files, conduct of pre-study and initiation visits and other duties as assigned (according to SOPs, ICH Guidelines and GCP).-Maintained an active role in the training and mentoring of new study monitors.-Acted as a liaison with lower level study monitors and site personnel assigned to the study. -Reviewed CRFs to identify erroneous, missing, incomplete or implausible data. -Responsible for developing, updating and tracking study tools, source documentation and monitoring conventions.-Provided direct site support and guidance to investigator sites for all study related matters.

-Monitored clinical research sites in a Phase III CNS study for safety, drug accountability and protocol compliance. -Indentified potential investigational sites-Produced comprehensive visit reports and status reports-Acted as the clinical contact between clinical sites and data management for data review and team training.-Conduct of pre-study, initiation, routine and closeout visits.

-Responsible for the site conduct of Phase III CNS studies. -Monitored subject safety, completed CRFs, assessed subject eligibility, and performed subject rating scales.-Recruited subjects for assigned clinical trials.-Reviewed protocols to organize and manage logistics of implementation at the site level.-Oversight of drug dispensation, accountability and reconciliation.

-Charged to organize logistics of Phase I studies of multiple therapeutic indications. -Managed assigned personnel in the creation of source documents, subject protocol compliance, CRF completion, adverse event follow-up, and query resolution.-Trained new study coordinators as neededMonitored study progression for reporting to study manager.