Megan Kroes Email & Phone Number

Nashville, Tennessee, United States

Nashville, Tennessee, United States

- Liaison between the Clinical Research Associates and upper management - Lead a team of Clinical Research Associates through end-to-end clinical trials and daily operations - Routinely present study status for sites to management team and lead weekly calls - Review trip reports for multiple protocols on an ongoing basis for quality and efficiency until - finalization - Build reports to maintain study data, daily activities, patient status, site monitoring, issue resolution, and expense reporting - Travel to identify, select, and initiate sites for ICON and their sponsors to meet subject recruitment needs and database locks in a timely manner as well as ensure these sites produce the highest standard quality of work - Train new employees in clinical research operations - Mentor existing employees through appropriate career development and training - Organize study information, employee documentation and audit responses to present to study sponsor - Worked with both local and central IRBs to maintain study approvals and regulatory standards for all sites involved in clinical trials - Ensured all sites were in compliance with the study protocol, ICH/GCP guidelines, FDA and local government regulations

Wilmington, Delaware, United States

- Traveled nationally more than 75% of the time, maintained budget standards, and consistently delivered quality work within recommended study timelines - Wrote exceptional monitoring reports with special attention to detail to provide ICON and our clients a clear picture of all study activities that occurred at each site visit - Liaison between site doctors, nursing staff, and pharmacist to build rapport and ensure a positive and professional working relationship is built and maintained - Managed assigned investigational study sites including the set-up and maintenance of main study files and site files, preparation of spreadsheets to track daily activities, and in-house support for the international study teams - Performed on-site quality reviews of case report form data to verify information against source documents - Conducted routine monitoring visits to ensure investigator and staff were in compliance with protocol, FDA regulations, ICH/GCP guidelines, and pertinent SOPs - Ensured informed consent is administered properly and appropriately advise sites of any execution violations detected - Performed drug accountability and reconciled counts with CRF, source data, and dispensing logs - Oversaw and evaluated subject enrollment, while compiling and reviewing patients’ status tracking information - Responsible for study start-up activities, which included pre-study visits and regulatory documentation review and submission