Jennie Pegram

Experience

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  Newport Aquarium

  Apr 2011 - Oct 2012

  Ride the Ducks

  Provided excellent customer service to guests and functioned as a resource for patrons seeking information about the area.

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  Cincinnati Children's Hospital Medical Center

  Aug 2012 - Apr 2013

  Research Assistant

  Investigated mechanisms of epilepsy (mTOR pathway) under Dr. Steve Danzer;Performed lab techniques such as DNA extraction and isolation, PCR and gel electrophoresis;Handled live mice in a sterile environment.Presented at Undergrad Capstone Conference

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  Medpace

  May 2013 - Nov 2014

  Project Coordinator

  Provided day-to-day departmental/project support activities, such as maintainence of project-related files and faxing documents to sites;Coordinated and provide minutes for department/project meetings or conference calls;Conducted quality control of documents;Maintained spreadsheets and compile reports; andPerformed other tasks as needed.Specialized in studies focus on Pancreatic Cancer, hypercholesterolemia and tinnitus.

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  University of Cincinnati Cancer Institute

  Nov 2014 - Apr 2016

  Regulatory Coordinator

  Prepared clinical trial regulatory submissions to central and local Institutional Review Boards (IRB);Drafted patient informed consent forms (ICFs) in compliance with IRB policy and procedures;Made modifications to protocols, ICFs and advertisements according to sponsor or IRB request;Prepared Investigational New Drug (IND) Application submissions for Investigator-Initiated studies for FDA submission;Typed technical and confidential correspondence for UC Cancer Institute and maintained high volume of regulatory files;Worked with clinical research staff and study sponsors' monitors to ensure quality control in regulatory documentation;Completed various reports for IRB and study sponsors.Trained new regulatory staff personnel on all responsibilities. Show less

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  CTI Clinical Trial and Consulting Services

  Apr 2016 - now

  Manage and serve as main CTI contact for investigative sites and provide updates to management and sponsor.Creates and implements subject enrollment strategies for assigned investigative sitesConducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the monitoring plan.Ensures proper storage, dispensation and accountability of all investigational product(s) and trial-related material.Maintains tracking records for assigned sites including tracking of subject status, subject CRF retrieval/ source document review, regulatory documents, and investigational productCompletes in-house monitoring activities as appropriate, such as updating in-house site files, conducting remote monitoring for EDC studies, and completing visit reports/ lettersAnticipates/identifies site issues and implements corrective actions or escalates to study manager/ sponsor as necessaryCompletes site selection and pre-study activities to identify and evaluate potential investigatorsParticipates in study-specific trainingConducts project-specific administrative activities as a member of the project teamAssists in the preparation and coordination of project investigator’s meetings and attends the meetings as necessaryAttends sponsor meetings as necessary.Increases knowledge of drug development process, therapeutic areas, Good Clinical Practices (GCPs) and any applicable local regulatory requirements Show less

  • Manager, Clinical Monitoring

    Jan 2022 - now

  • Senior Clinical Research Associate

    May 2021 - Jan 2022

  • Clinical Research Associate

    Jul 2017 - Jan 2022

  • In-House Clinical Research Associate

    Apr 2016 - Jul 2017