Study start-up activitiesReview regulatory documents for content, consistency with other documents, as well as compliance with regulatory requirements/guidelinesDevelop training content and outlines for ePS systemsCo-design the user administration process with User Admin/QC and ITManage all site and user requests from the client from inception through completion of the programPrepare role matrices, supporting documentation and workspace change/update requests for the projectInteract with clients, study team and third-party personnel as requiredPlan, coordinate and handle all project scheduling, logistics and administrative tasks-Adhere to timelines and provides other needed support to the project teamHandle other duties as needed

Responsible for the preparation of all clinical study documents (e.g. protocol, CRFs, forms and manuals, ICFs, IRB Approvals, 1572s) and presentation material Assembled/distributed regulatory packages (as well as Confidentiality Agreements and Clinical Trial Agreements) Supported and assisted with study site management, including liaising with site staff and RCRAs for document retrieval and submissionTracked, filed, maintained and audited regulatory documents for the clinical TMF Audited and maintained TMF including discrepancy follow-up and generation of Notes-to-Files, as appropriateAssisted with IRB submission preparation and study site set up for initiation Collected, reviewed, tracked and maintained site regulatory documents as part of study start-up and study closure activitiesPrepared correspondence/memos/newsletters for distribution Created bookmarks and Appendices for BLA submissionSupported Clinical Operations Lead as part of multi-functional study team to meet timelines and milestonesUpdated team rosters, investigator lists and other study specific tracking documentsServed as contact for internal departments and external vendors Arranged, tracked and followed up on study payments as requiredFamiliarization with ICH Good Clinical Practice Guidance

for Oncology and Cardiovascular Therapeutic Areas Reviewed required regulatory financial and legal documents from study sites for quality and accuracyHandled site follow-up for resolution of data queries and interacted with sites to resolve regulatory and financial document discrepanciesAssisted in the distribution of weekly IND Safety Letters to investigators and tracking of necessary follow-up reports as appropriateAssured accuracy of required clinical trial documents within Central Files (ie, CVs, FDA 1572, Lab Certification, Financial Disclosure and lab normal's, etc) throughout the clinical trial Processed investigator and patient grant payment request and corresponding cover letters for distribution to Sanofi-Aventis Finance/Legal Dept and Clinical InvestigatorsProcessed and circulated Contract Amendment tracking maintaining clinical grant tracking database for each studyGenerated periodic reports on status of grant payments and resolved payment inquiries from investigator sitesAssisted CPL/CRA in preparing and tracking investigational product (IP) supplies, packaging, and shipment requests and circulating these requests for appropriate approvalsConfirmed site receipt of shipped IP and assisted with drug reconciliation, relabeling and expirationManaged inventory of study conduct tools and non-drug clinical supplies Assisted on up to 2-3 studies at a time maintaining study and site information in Company's data base systems ie Access, Share drive, Arco, and ImpactCoordinated mass mailings/faxes to study sites and managed/created spreadsheets for multiple studies via ExcelAssisted with archiving and auditing Regulatory documents for Cardiovascular and Oncology studies

Collected, reviewed, and tracked regulatory and non-regulatory documents for Trip Report distributionInitiated and maintained production on study documents as assigned ensuring template complianceInterfaced with RPS sponsors and CRAs for effective delivery of a study and its regulatory documents and case report formsAssisted to clinical study start-up, reconciling accounts, and execution reporting and coordinate administrative tasks during study processSet-up, populated, and accurately maintained information in Study Delivery systems (eqTrakWare, CRNets) and share drives to support others in the usage of these systems as appropriateContributed to coordination and tracking of study related supplies, equipment, and documents and assist with 800-lineCoordinated meeting arrangements, appointments, and schedules for the preparation of internal and external meetingsRecorded and distributed meeting minutes for Study Team internal and external meetingsBatched and expedited Trip Reports including submitting RPS expense reports and correcting inconsistencies for Share DriveUpdated Clinical Affairs Employee List via Access and maintained Management and PTO CalendarsPerformed data entry and checked quality, consistency, and integration of clinical study data including formatting resumes by following company guidelinesAssisted Executive Director of Regional Monitoring and three Assistant Directors for regional monitoring programPlanned and scheduled accommodations for regional CRA's and updated monthly workload data and site assignmentsOrganized and prepared training materials for CRA training and organized protocols for site assignments for CRA'sCompleted Project Assistant activities according to ICH-GCP requirements under the Standard Operating Procedures and Policies of Client Company

Assisted peers with web-based job search and observed resume critiquesDeveloped and facilitated career workshops /educated campus community on services offered by the centerUtilized marketing techniques to advertise workshops and career fairs

Assisted with direct e-mail, fax, and/or paper mailings to area resourcesGathered materials for advertising and distributionDirectly involved in the recruitment and screening of resumesScheduled qualified applicants for interviews and orientationsCompleted all necessary paperwork, checked references, and conducted background checks

Created and maintained spreadsheets including composing PowerPoint presentationsComposed correspondence and performed research duties as neededAssisted managers with employee appraisals and benefits and scanned documentsCoordinated and scheduled internal meetings appointments and presentations for managersMaintained calendar and filling system and scheduled appointments and prepared detailed itineraries and travel accommodationsTracked and prepared expense reports, screened calls, visitors, and letters

Supervised up to 25 employees, evaluated employee performances, and handled EEO issuesDirected and trained employees/supervisors on daily routine and objectivesReported and maintained files on all input work-related injuriesDeveloped the safety calendar and disseminated all safety-related materialsOrganized and facilitated weekly focus group meetings and recognition programs for productionCoordinated and scheduled employees to assure appropriate staffing levelsChecked time and attendance records and compiled and submitted payroll for approval