Lindsay Cortright

Experience

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  East Carolina University

  Jan 2015 - Dec 2016

  Graduate Research Assistant

  Created interview, survey, & other data collection instruments, recruiting participants, qualitative & quantitative data analysis, and co-authoring manuscripts and presentations. Key accomplishments include developing a training program for new team members, co-authoring two manuscripts and assisting with interdisciplinary literature reviews for manuscripts and grant applications, as well as website maintenance and data visualization presentations designed for scientific and non-scientific audiences. Show less

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  The Brody School of Medicine at East Carolina University

  Jul 2016 - May 2020

  Train and supervise research staff in the department of pediatrics in research design and conduct, project development and implementation, quality and risk management, SOP development, mentorship, and stakeholder collaboration. Key accomplishments include developing a clinical research on-boarding program, leading an undergraduate Child Health Research Internship producing 15 finished manuscripts and 3 published thus far, and co-authoring 15 manuscripts and coordinating over 20 ongoing research projects and 9 additional manuscripts.Specific duties include: - Executive planning and oversight of internal pediatric clinical research projects- Oversee regulatory submissions and compliance - Writing and editing protocols, manuscripts, and research reports for internal projects- Data management, including developing databases and data dictionaries, overseeing data security and storage, and data cleaning. - Building processes and workflows for study conduct, and developing corrective and preventive action plans when errors are discovered- Developing training programs and mentoring new faculty and staff as well as other collaborators new to research Show less Coordinated research projects in pediatric hematology, including feasibility assessment and start up, budget negotiation and invoicing, writing patient-centered documents, and regulatory management. Key accomplishments include leading our the team to become the highest pediatrics-only enrolling site on 3 protocols, presenting best practices in data entry, management, and protocol compliance, training 4 new research coordinators and 2 interns, and starting up 6 additional trials.Specific duties included:- Coordinating student projects, databases, collaborations with other institutions, and industry-sponsored clinical trials- Determining project feasibility, developing project budgets, and tracking project expenses and income- Writing consent forms, preparing regulatory documents, and IRB submissions - Building processes and workflows for complex study protocols that ensure appropriate human subject protections, protocol adherence, GCP and FDA compliant documentation, and efficient data entry - Creating and maintaining source documentation, databases, and codebooks - Coordinating with pharmacy, the laboratory, nursing staff, imaging, physicians, and other coordinators to ensure proper training, documentation, and protocol adherence Show less

  • Clinical Research Project Manager

    Jul 2018 - May 2020

  • Clinical Research Coordinator

    Jul 2016 - Jun 2018
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  University of North Carolina at Chapel Hill

  Jun 2020 - now

  Manage all aspects of multi-site investigator-initiated investigational studies (including investigational drug, device, and registry studies) from start-up to close-out: develop protocols, manuals of operations, data and safety monitoring plans; maintain regulatory compliance; coordinate meetings and trainings; maintain relationships with subsites and collaborating centers; author and disseminate study communications; create and maintain databases; co-author manuscripts and presentations; train and supervise research staff. Show less

  • Senior Research Project Manager

    Jun 2022 - now

  • Research Project Manager

    Jun 2020 - May 2022