Alison Hart Email & Phone Number

Denver, Co, Us

Research Triangle Park, Nc, Us

Morrisville, Nc, Us

Morrisville, Nc, Us

Raleigh, North Carolina, Us

Raleigh, North Carolina, Us

Morrisville, Nc, Us

Role as project manager on 5 site pediatric PK trial (Jun 07 – Dec 08);Role as project manager on 2 single site induced fever trials;Development and review protocol/study design, case report forms, informed consent forms and other documents;Identify and recruit investigators; Develop patient recruitment strategies and materials;Coordinates Clinical Monitors on-site and in-house monitoring responsibilities, schedules and overall project related day-to-day management of the monitoring team;Manages aspects of the clinical projects including development of the Project Operations Manual (POM) and the Clinical Monitoring Plan (CMP) and the review and sign-off of monitoring reports (including tracking of reports and assurance of visit frequency per CMP/contract; Prepares of the monthly status report;Prepares source documentation and assist in generation of CRF guidelines;Identifies, recruits and manages central lab, ECG, ABPM, drug labeling, packaging and distribution, Holter, IVRS as required per project scope;Supervises Clinical Assistant(s) assigned to project teams for project related scope;Ensures study master files comply with SOPs, GCPs and other regulations;Prepares for and leads/attends project team meetings and provides updates of project performance;Designs and develops investigator, regulatory, operations, guidelines and training manuals;Prepares for and attends project launch meetings;Prepares for and lead/attends client meetings; provides follow up with client regarding any study issues as requested by Project Manager

Morrisville, Nc, Us

Manages all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrityScientifically monitors clinical studies, which includes the review of case report forms (CRFs) to ensure adherence to the protocol and consistency and scientific validity of the dataProvides technical and scientific guidance to study site personnel to ensure consistency in interpretation and exchange of scientific information in clinical trialsAssists in generation and review of source documents and CRF guidelinesManages query resolution process with sites and Premier Data ManagementPrepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits to investigator sitesPrepares for and attends project launch meetingsDirects the tracking of enrollment rates, receipt and review of completed CRFs and grant documentation to ensure the efficient execution of a clinical trialPrepares Monitoring Trip Reports and contributes information for Status Reports for sponsorsAssists in the preparation and development of materials for Investigators' Meeting. Attends Investigators' Meeting as designated by Project ManagerManages investigative sites via telephone calls between visitsAdherence to study timeline and budgetPerforms overnight travel as requiredAll other projects as assigned

Scientifically monitors clinical studies, which includes the review of CRFs to ensure adherence to the protocol and consistency and scientific validity of the dataProvides technical and scientific guidance to study site personnel to ensure consistency in interpretation and exchange of scientific information in clinical trialsAssists in generation and review of source documents and CRF guidelinesPrepares Monitoring Trip Reports and contributes information for Status Reports for sponsorsAssists in the preparation and development of materials for Investigators' Meeting. Attends Investigators' Meeting as designated by Project ManagerManages investigative sites via telephone calls between visitsAdherence to study timeline and budgetPerforms overnight travel as requiredAll other projects as assigned

Pittsburgh, Pennsylvania, Us

Designed surveys for mail and face-to-face interviewsAnalyzed data using SPSSCoordinated study of departmental organization and communicationCompleted IRB submissionsConducted chart reviewed for outcomes research studies

Coordinator multiple Phase II-IV clinical trials in Women's HealthCreated source documentsCompleted CRFs and eCRFsResponded to data management queriesParticipated in the informed consent process

Pittsburgh, Pa, Us

Conducted ligand-binding assays and behavioral studies with small lab animalsAnalyzed data for publication using statistical softwareManaged all aspects of the research laboratory