Experience

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  Scout Bio

  • Senior Clinical Research Associate

    • May 2024 - Present

    -Assume a leadership role in the conduct of clinical studies ad the preparation of data and submission of reports to FDA/CVM/applicable regulatory authority-Assume responsibility for a team of internal and external clinical trial associates as well as additional study team members- Plan and execute clinical studies ensuring that deliverable are completed on time and within budget-Create and manage reports that detail the clinical study progress such as subject screening and enrollment, data collection, documentation of adverse events, and payments-Development of protocols-Writing and submission of Final Study Reports -Data submission packaging for submission of studies to country specific regulatory authorities-Develop and manage study related documents and materials such as investigational plans, case report forms, study manuals, monitoring plan, informed consents, websites, recruitment materials and other study related tools-Participate in site qualification and initiation activities, including training of investigators and coordinators. -Participate in FDA Inspections-Coordinate and conduct monitoring visits at investigative sites to ensure compliance to the investigational plans, regulations, and timely receipt of data, including source document verification, device accountability, and writing of monitoring visit reports-Verify appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements-Management of investigative sites to ensure sponsor support of trial activities and oversight of site compliance-Development and implement site corrective actions as needed to address any noncompliance issues-Assist in planning, preparing, and presenting materials for investigator and coordinator meetings-Maintain current working knowledge of the disease state and product-Oversee development and management of clinical database

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  Global Innovation Boehringer Ingelheim Animal Health - US

  • St. Joseph, Missouri Area

  • Senior Clinical Research Associate

    • Mar 2019 - Apr 2024
    • St. Joseph, Missouri Area

    -Assume a leadership role in the conduct of clinical studies ad the preparation of data and submission of reports to FDA/CVM/applicable regulatory authority-Assume responsibility for a team of internal and external clinical trial associates as well as additional study team members- Plan and execute clinical studies ensuring that deliverable are completed on time and within budget-Create and manage reports that detail the clinical study progress such as subject screening and enrollment, data collection, documentation of adverse events, and payments-Development of protocols-Writing and submission of Final Study Reports -Data submission packaging for submission of studies to country specific regulatory authorities-Develop and manage study related documents and materials such as investigational plans, case report forms, study manuals, monitoring plan, informed consents, websites, recruitment materials and other study related tools-Participate in site qualification and initiation activities, including training of investigators and coordinators. -Participate in FDA Inspections-Coordinate and conduct monitoring visits at investigative sites to ensure compliance to the investigational plans, regulations, and timely receipt of data, including source document verification, device accountability, and writing of monitoring visit reports-Verify appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements-Management of investigative sites to ensure sponsor support of trial activities and oversight of site compliance-Development and implement site corrective actions as needed to address any noncompliance issues-Assist in planning, preparing, and presenting materials for investigator and coordinator meetings-Maintain current working knowledge of the disease state and product-Oversee development and management of clinical database

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  Boehringer Ingelheim Animal Health - US

  • St. Joseph, Missouri Area

  • Clinical Research Associate

    • Aug 2012 - Mar 2019
    • St. Joseph, Missouri Area

    - Plan and execute clinical studies ensuring that deliverable are completed on time and within budget-Create and manage reports that detail the clinical study progress such as subject screening and enrollment, data collection, documentation of adverse events, and payments-Development of protocols-Writing and submission of Final Study Reports -Data submission packaging for submission of studies to CVM/FDA-Develop and manage study related documents and materials such as investigational plans, case report forms, study manuals, monitoring plan, informed consents, websites, recruitment materials and other study related tools-Participate in site qualification and initiation activities, including training of investigators and coordinators. -Participate in FDA Inspections-Coordinate and conduct monitoring visits at investigative sites to ensure compliance to the investigational plans, regulations, and timely receipt of data, including source document verification, device accountability, and writing of monitoring visit reports-Verify appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements-Management of investigative sites to ensure sponsor support of trial activities and oversight of site compliance-Development and implement site corrective actions as needed to address any noncompliance issues-Assist in planning, preparing, and presenting materials for investigator and coordinator meetings-Assist with vendor management to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work-Participate in regular project team meetings-Maintain current working knowledge of the disease state and product-May assist clinical manager by providing input to sections of clinical reports for FDA and abstracts/manuscriptsOversee development and management of clinical database for the trial