Managed project scope, budget, quality, timelines, and deliverables, as well as client relationships to facilitate the delivery of IXRS products for clinical trials.Coordinated internal and external stakeholders to ensure timely completion of deliverables over the life span of an IXRS project.Identified, mitigated, and managed project risks.Lead internal efforts to define the resources needed for projects and requested additional team members if necessary.Performed regular analysis of ongoing trials to ensure emergent system needs were addressed

Completed essential document collection and review throughout the study lifecycle inclusive of site activationOrganized and maintained site clinical trial master file (TMF) documentsEnsured activities, documents and all other clinical data were accurately tracked and documented for the project lifecycleActed as a primary site contact for study and site management issuesAssisted project teams with identifying study sites, performing site feasibility, and recruitment tasks

Coordinated all site level conduct of Phase I oncology trialsActed as a protocol expert on trial operations for local institutional staffResponsible for creating and maintaining source documentation in EPIC, sponsor EDCs, and paper charts per ALCOA-CScreened, consented, and scheduled research participants in compliance protocol defined requirements and timelinesEnsured potential subjects’ eligibility prior to registration on trialsAssisted investigators in monitoring for and assessing emergent adverse events in trial subjects

Trained all faculty and staff on the proper usage of the OnCore CTMS system. Additionally hosted retraining opportunities on an as needed basisResponsible for the development and implementation of process improvement projects aimed at improving operational efficiencyCreated and maintained reports on trial status and accrual data for leadershipPerformed data validation and quality checks on an ongoing basisAssisted end users by acting as a help desk for systems issues or operational questionsServed as a SME for IT staff on research operations and proceduresHeld membership on the Office of Clinical Research Policy Committee and Education Committee

Prepared, processed, and maintained all documentation for both local and external regulatory reviewsHosted sponsor initiation, monitoring, and close-out visits

Worked within trial project teams charged with the operational management of global clinical trialsAuthored clinical trial and site related documentation including Investigator Site File documentsManaged vendors responsible for outsourced trial functions(e.g. eTMF, eCRF, Central Lab)Updated and maintained in-house clinical trial systems(e.g. CTMS, Contracts, web-based trial portals)Reviewed essential site and study level documentation for quality, accuracy, and completenessCollaborated with other global study team members in monitoring the progress of trials from study startup to database lockOrdered, tracked, and distributed trial-related supplies

Served as a Project Manager of Investigator-Initiated research in oncologyAssembled cross-functional teams of stakeholders to develop research proposals into clinical trialsAuthored Protocol Documents, Consent Forms, Site Training Materials, and other necessary study documentsProvided guidance on regulatory submission requirements (IND/IDE)Assisted investigators with site selection and feasibility determinationsRequested and managed regulatory documentation for all sitesMonitored trial progress at all sites to ensure adequate accrual and patient safetyProgrammed an Access database for the creation of standardized project plans with timelines, milestones, and reportable metricsDeveloped automated weekly reports showing all trial statuses to senior leadership on all investigator-initiated projects

Requested and reviewed regulatory documentation from domestic and international sites participating in oncology clinical trials sponsored by the National Cancer InstituteEnsured participation site regulatory and protocol complianceResponsible for contacting sites regarding incorrect or missing documentationManaged the Cancer Therapy Evaluation Program database of protocol and site level regulatory requirementsServed as a point of contact for participating sites by providing guidance on regulatory compliance and enrollment issuesFacilitated communication between Site Personnel, Investigators, IRBs, the NCI, Cooperative Groups, and Pharmaceutical Sponsors

Taught effective parenting skills and information on childhood development to adults whose children had been temporarily removed by the state.Worked as part of a three person interdisciplinary team including a Social worker and Psychologist. Organized community events and social support groups for clients.Coordinated with and reported to local and state government agencies

Developed, enacted, and monitored outcomes of behavioral treatment plans for autistic adults.Established and utilized contacts within private industry, educational institutions, and government agencies.Assisted individuals in seeking out and applying to gainful employment opportunities.Responsible for teaching effective interviewing skills and resume building.Developed essential daily, monthly, and quarterly note forms for the entire office.Created promotional materials highlighting company services to potential employers.

Implemented programs to foster resident growth socially and academically.Performed administrative duties related to student housing.Acted as an arbitrator in residential disputes.

Aided adults with severe mental health issues such as schizophrenia and borderline personality disorder in developing independent living skills.Responsible for disseminating medications to residents daily