Karin G. Email & Phone Number

San Carlos, California, United States

• In-house CRA for Sponsor • Co-authored clinical study documents• Responsible for sample monitoring, oversight, and reconciliation• Perform all levels of site management• Proficient in site qualification, site selection, site initiation, routine monitoring, and remote monitoring visits• Source data verification• Ensure investigator site compliance with FDA regulations, ICH/GCP guidelines, Sponsor protocol, site SOPs, and ensure subject safety is prioritized• Monitoring report reviews• Proactively communicate and follow-up• Consult with medical and data management team members to ensure subject safety, accurate data, and scientific elements are understood by applicable study team members• Collaborate with the Clinical Operations team in the creation and refining of processes and documents• Prepare agendas and meeting minutes, present and lead meetings• Cross-functional team and vendor experience

Remote

• Working with Sponsor, Vaxcyte, on vaccine clinical trials• Collaborate with the Clinical Operations team in the creation of processes and documents• Create an interim Trial Master File structure• Reorganize and rename files in a coherent manner• Transfer, reconcile and QC Trial Master File documents between systems• Follow the SOP document revision process until all QC issues are resolved• Set up and maintain study trackers and data management documents• Collect and review essential regulatory documents• Produce Clinical Operations TMF meeting agendas and participate in meetings• Create Simple Trials report templates• Proficient with Microsoft Outlook, Zoom, WebEx, Smartsheet, Excel, EDCs, Simple Trials

Germantown, Maryland, United States

• Within 1 month, promoted to Team Lead• Lead, manage, and train teams of healthcare professionals to execute quality corporate screening events • Act as the business- to- business liaison • Provide empathetic and problem-solving focused customer service • Continuing education with multiple certifications• Perform multiple types of medical tests and screenings, adhering to GCP and HIPAA regulations • Document and interpret patient data• Help clients understand their results as well as teach them practical ways to increase their wellness

Burlington, North Carolina, United States

• Manage and train teams of healthcare professionals to execute quality corporate wellness screenings• Train team on SOPs, Protocol and OSHA regulations to ensure compliance during events• Review and reconcile source data• Document and interpret patient data using EDC systems• Act as the business- to- business liaison • Coach clients on maintaining or changing biometrics, cholesterol and glucose numbers• Continuing education with multiple certifications• Perform manual blood pressure and multiple screenings, adhering to GCP and HIPAA regulations

Austin, Texas Area

• Utilize organization and effective communication skills• Develop and maintain customer relationships• Create systems and documents to support scaling business• Use sales and strategic marketing skills to find and grow business• Identify and meet the needs of each client, providing concierge customer service• Adept in Client Relationship Management systems (specifically LACRM and TESS)

Secaucus, New Jersey, United States

• Set up and execute quality corporate onsite screening events • Provide empathetic and problem-solving focused customer service • Continuing education with multiple certifications• Perform multiple types of medical tests and screenings, adhering to GCP and HIPAA regulations • Document and interpret patient data• Help clients understand their results as well as teach them practical ways to increase their wellness

Austin, Texas Area

• Within 3 months, promoted to Team Lead• Within 1 year, promoted to Trainer• Lead teams of healthcare professionals• Set up and execute efficient and high quality corporate screening events• Act as business-to-business liaison• Assign roles and manage staff• Train and educate new staff• Provide empathetic and problem-solving focused customer service• Manage efficient flow of event• Teach and coach clients how to apply new knowledge• Research new health information• Create a positive team and clinical environment• Develop and maintain positive client relationships• Model and encourage collaboration and feedback

*Set up and execute high quality corporate health screenings*Adhere to HIPAA protocol*Collect accurate biometric results*Teach clients about their bloodwork results*Coach clients to practically improve their wellness*Collaborate with co-workers for continuous improvement in soft and hard skills*Research current health information

While we raised our 4 children, I was thankful for the opportunity to stay home with them. During those years, I was involved in a variety of part-time work, volunteer activities, and trainings that are too numerous to list. I took advantage of groups and classes, both online and in person, where I continued to develop my technical, personal growth and leadership skills. In addition, I was able to travel internationally and assist with a non-profit in Africa, which ignited a passion for global health.

Lynchburg, Virginia Area

*Long Term Substitute Reading Specialist at a Title I school*Teaching and implementing reading skills with small groups *Planning applicable lessons tailored to the learning styles of individual students *Implementing lessons *Assessing student's learning and adjusting lesson plans accordingly

Alexandria, Mn

*Good patient rapport development and communication*Patient data collection, reports, and filing*Performing technical vision and diagnostic screening*Effective communication with the ophthalmologist and office team