Karlie Morgan

Experience

• 

  Private Care

  May 2004 - Jul 2005

  Personal Care Assitant

  - Provided compassionate care for a blind adult with down syndrome and limited mobility- Enhanced social and behavioral development by providing educational and rehabilitative services

• 

  North Arkansas Regional Medical Center

  May 2005 - Jul 2006

  Emergency Room Technician

  - Assisted medical personnel with emergency patient care, administrative duties, and clinical tasks- Responsible for maintaining supply inventory, patient data collection, and record management- CPR and First Aid Certification; HIPAA and JCAHO trained

• 

  Medtronic

  Nov 2010 - Nov 2011

  Diabetes Therapy Associate

  - Developed and maintained collaborative relationships with patients, healthcare providers, and company representatives as an inside sales team member- Coordinated all aspects of insulin pump and continuous glucose monitoring system therapy sales- Corresponded with insurance companies for product coverage approval; educated patients on product technology; performed high volume document and data collection

• 

  ArthroCare Corporation

  May 2012 - Mar 2013

  Clinical Research Associate I

  -Member of a cross-functional team interfacing with marketing, sales, legal, and medical education to accomplish the development and execution of Wound, Sports Medicine, and ENT clinical studies-Completed literature reviews and risk analyses projections-Developed protocol synopses and presented to KOLs to ensure alignment with standard of care practices-Assisted in the development of protocols, consents, monitoring plans, study reference guides, and CRFs-Collaborated with CROs through the development of databases including eCRF build, UAT, and go live as well as review of Data Management Plans, Statistical Analysis Plans, and DSMB charters-Assisted in Investigator on-boarding process by performing background checks, assisting in execution of -Investigator Meetings, and performing site trainings-Oversight of French translation for study documents-Managed French and US EC submissions-Tracked screening, enrollment, and subject status metrics Show less

• 

  ArthoCare Corporation

  Mar 2013 - Jan 2015

  Clinical Research Associate II

  -Lead CRA for US and OUS Wound and Sports Medicine clinical studies -Ensured all clinical activities were performed in compliance with corporate and departmental SOPs, GCP, and regulatory requirements-Managed budgets and ensured payments were made in accordance with executed agreements-Ensured maintenance of audit-ready study files in-house as well as at study sites-Provided accurate and timely study metrics to senior management-Planned and performed Site Qualification, Initiation, and Interim Monitoring visits-Responsible for oversight of study sites including data integrity, adherence to protocol, monitoring, and enrollment activities-Attended surgical procedures to direct device use, ensure protocol compliance, and support randomization Show less

• 

  Smith & Nephew

  Jan 2015 - Apr 2020

  -Design and manage multiple US clinical studies in Sports Medicine and Orthopaedic Reconstruction to determine safety, performance, and efficacy of devices -Develop clinical study protocols, informed consents, monitoring plans, clinical study reports and other related documents-Support development of and approve data management documents including CRFs, completion guidelines, edit specifications, and data management plans; complete EDC user agreement tests-Negotiate contracts with and manage CROs for biostatistics, data management, medical and safety monitoring, and imaging; support development of associated CRO study documents-Responsible for clinical study budget creation, forecasting, and spend tracking and reporting-Ensure successful study start-up through investigator identification and training, monitor training, oversight of contract and budget negotiations, EC submission support, and site visit management-Coordinate and support FDA PMA supplement and annual report submissions -Maintain accurate, high quality data through adherence to protocol and monitoring plan-Ensure audit readiness by following SOPs and performing frequent self-audits of study documents -Responsible for developing, tracking and reporting study metrics to asses study performance, site start-up activities, screening and enrollment, subject visits and CRO activities-Support project close-out activities including completion of site visits, analyses, review and approval of AE and drug coding reports, clinical study reports, abstracts-Act as a peer advisor and mentor to junior study managers and new hires Show less -Designed and managed multiple US clinical studies in Sports Medicine and Robotics-Authored study documents including protocols, consents, monitoring plans, and CRFs-Coordinated and facilitated Investigator Meetings and cadaver labs-Performed and managed CRA completion of site monitoring visits; trained monitors on departmental SOPs and study materials-Collaborated with internal departments and CROs for CRFs, EDCs, and budget and contract development-Supported Interim Analyses and Data and Safety Monitoring Board meetings through extensive monitoring, contribution to the SAP, collaboration with the CRO to prepare tables and listings, organization of meetings and development of meeting materials-Responsible for study closure activities including oversight of site visits, notifying Investigators and ECs, final review of clinical study documentation, device reconciliation and accountability, authoring Clinical Study Reports, and archiving files-On-site Clinical team representative for internal audits-Functioned as the Organizational Change Management Co-lead for eTMF initiative-Reviewed and revised clinical department SOPs; collaborated with clinical team to develop and implement a SOP transfer plan Show less

  • Senior Clinical Study Manager

    Jan 2017 - Apr 2020

  • Clinical Study Manager

    Jan 2015 - Jan 2017
• 

  Smith+Nephew

  Apr 2020 - now

  Responsible for training and management of US Global Clinical Operations team and their activities across all S+N franchises to ensure that assigned programs of work are executed in a timely, compliant and efficient manner. Responsible for full vendor oversight in order to ensure quality and timely study execution, collaborative study teamwork and alignment between the vendor and the business.

  • Regional Clinical Operations Manager, USA

    May 2022 - now

  • Sr. Clinical Manager

    Jul 2021 - May 2022

  • Clinical Manager

    Apr 2020 - Jul 2021