Heather Orr Email & Phone Number

As the Lead CRA/Project Manager, responsibilities included: Managing all CRA activities; coordinating and overseeing quality of study start-up activities; scheduling and conducting of pre-study site assessments, initiations and actively contributing to final site selection. Effectively motivating CRA and study coordinator teams to meet enrollment targets, CRF completion and query resolution within timelines. I assisted in writing protocol amendments, ICFs, CRFs, CRF guidelines, and project manuals. Reviewing project budgets and assisting in outlaying out of scope items. Reviewing/tracking enrollment metrics and protocol violations along with identifying project issues across the study. Periodically conducting training in all aspects of clinical monitoring and protocol-specific with CRAs; participating in the planning, implementation and presentation at investigator meetings. Assisting the Assistant Director Clinical Operations CRA resourcing, evaluations and training. Along with developing of standardized tools for clinical monitoring of projects.As a Senior Regional CRA, responsibilities included: identifying and contacting potential investigators, adhering to SOPs; identifying issues and problems to be addressed by the Project Manager. In addition, responsibilities included: conducting all types of monitoring visits. Collecting and reviewing regulatory documents. Coordinating shipments of Investigational Product. With regard to study monitoring, responsibilities included: evaluating overall site performance, ensuring Investigator’s adherence to protocol, reviewing CRFs, performing SDV, reviewing AEs, coordinating documents for the Endpoint Validation Committee, preparing and resolving queries, performing Investigational product accountability, completing trip reports, and maintaining accurate study files.Specialties: Regulatory, Project Management, Study Start-up, Monitoring, Lead CRA

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  Grand Valley State University

  Management