Detailed oriented research professional experienced in managing Phase I-IV clinical drug trials, both international and domestic.

Project Manager II @ Veristat is a premier CRO, successfully supporting clinical research trials for pharmaceutical, biotech, and medical device companies in the areas of Biostatistics, Statistical Programming, Clinical Data Management, Clinical Monitoring and Medical Writing Responsible for managing more complex and high profile clinical projects and/or programs, the Project Manager II provides management and leadership to plan, prepare and execute multiple high quality clinical projects and/or programs Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures; Tracks the clinical budget consumption through regular review of project budget reports Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to; Collect information on team performance against contract, customer expectations, and project baselines Identify quality issues within the study to implement appropriate corrective action plans; Lead problem solving and resolution efforts to include management of risk, contingencies and issues; Prepare and present project summary data at internal and external meetings in visible environments From March 2013 to Present (2 years 8 months) Project Manager, TIMI Study Group @ TIMI Study Group is a CRO that provides academic trial leadership, global trial management, biostatistics services, clinical events adjudication, safety monitoring and a 24 hour medical hotline Manage large-scale outcome driven cardiovascular clinical trials. Oversee site management and remote monitoring teams; supervise multiple direct reports; Responsible for all aspects of project management and administration of multicenter clinical trials, both domestic and international Manage Scope of Work (SOW); Provide day-to-day management of global on-site monitoring team; Develop, track and evaluate performance measures for subcontracted vendors providing services in data management, statistics, event adjudication, lab processing, monitoring and drug dispensing Present project summary data at internal and external meetings in visible environments; Develop and deliver global communications; e.g. newsletters, numbered memoranda; Develop study documents; e.g. project operating plans, protocols, ICFs, eCRF guidelines; Develop SOPs to streamline internal operations; e.g. Trial Team Reporting Structure Provide training and mentorship to project managers to deliver company’s mission; Performs other tasks and responsibilities are directed by the Director, Administrator, and/or Study Chairman From June 2010 to March 2013 (2 years 10 months) Lead Clinical Research Associate @ Design data collection forms, case record forms (CRFs) and source documents; Manage and coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects and applicable regulatory authority applications Locate and assess the suitability of facilities at a study center; Set up the study centers, which includes ensuring each center has the trial materials and training site staff to trial-specific industry standards; Interact closely with the investigator site to manage the trial level logistics ensuring compliance with protocol and completion according to study timelines; Coach the investigator site in GCP compliance/process improvement as necessary Monitor the trial throughout its duration, which involves visiting the study centers on a regular basis; verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV) Collect completed CRFs from hospitals and general practices; file and collate trial documentation and reports; Ensure all unused trial supplies are accounted for; archiving study documentation and correspondence Write visit reports; Prepare final reports; Close down study centers on completion of the trial From June 2009 to July 2010 (1 year 2 months) Clinical Site Manager @ Responsible for the site management, maintenance and oversight of day to day tasks and functionality; creation and implementation of site SOP’s, laboratory manual, training modules, procedures and processes to ensure high level of QC and QA Responsible for the oversight of human clinical trials, across multiple therapeutic areas ensuring compliance with ICH/GCP/FDA regulations through proper documentation, application of procedural SOP’s and staff training; identifies potential issues and implement contingency plans as needed Assess feasibility of conducting studies; key site contact for pharmaceutical company sponsors during trial initiation, start up, maintenance and close out Responsible for subject recruitment; finances for advertising; screening and enrolling subjects in outpatient clinical trials Administer informed consent process, conduct study visit per the protocol and ICH/GCP guidelines; maintain source documentation and complete paper and electronic Case Report Forms; perform routine quality assurance checks on data Dispense investigational medication and maintain drug accountability; Monitor subject progress with IRB/Sponsor notification of adverse events or SAE experiences From October 2007 to June 2009 (1 year 9 months) Epidemiologist Research Associate @ In collaboration with Epidemiologists/Project Managers, assisted in protocol development and proposed clinical trial ideas, with the main focus being Phase IV trials Contract with outside vendors/consultants to aid in development of clinical trials, draft contracts and financial agreements, key site contact for outside consultants Import data into United Health Care database to review and abstract patient data essential for study recruitment, draft letters to UHC providers requesting patient medical records Responsible for coordinating and developing supporting tools in order to train outside abstraction firms and consultants contracted to obtain patient medical records from UHC providers across the United States Correspond with IRB/Privacy Board for clinical trial approval and waivers of authorization of consents Schedule and attend weekly team meetings, Advisory Board Meetings and Scientific Review Board meetings, draft a synopsis of all topics discussed and retain for information From January 2007 to October 2007 (10 months) Lead Clinical Research Coordinator @ Responsible for oversight of multiple human clinical drug trials, across multiple therapeutic areas, ensuring compliance with ICH/GCP/FDA regulatory regulations through proper documentation, application of procedural SOPs and staff training Key site contact for pharmaceutical company sponsors during trial initiation, start-up, maintenance and close-out. Effectively maintained a working relationship with sponsors for the duration of each project through regular communication and proactive identification of challenges Supervised and trained new employees as well as student interns via shadowing, hands-on demonstrations and computer-directed courses Responsible for screening and enrolling patients in outpatient clinical trials Administer Informed Consent process, conduct patient study visits per protocol and ICH/GCP guidelines, maintains source documentation and completes Case Report Forms Performed routine quality assurance checks of study data Dispensed investigational medication and maintain drug accountability From January 2004 to January 2007 (3 years 1 month)

Michelle Corsi is skilled in: Clinical Research, Clinical Trials, GCP, Project Management, Regulatory Submissions, Clinical Monitoring, CRO, Clinical Data Management, Sop, Protocol, Clinical Development, ICH-GCP, EDC, SOP, Biotechnology