Brianna Armstrong Email & Phone Number

Chicago, Il, Us

- Managed Trial Master File (TMF) oversight for key studies, ensuring seamless coordination across all project stages.- Collaborated with internal and external project teams to develop robust electronic Trial Master File (eTMF) plans, including detailed TMF maps and system configurations.- Aided in the enhancement of the Veeva Vault eTMF system through precise configuration updates and meticulous user acceptance testing.- Generated critical eTMF metrics, provide insightful analyses for assigned studies, and implement prompt escalation procedures to maintain study integrity.- Act as the TMF SME for Clinical Research Organizations (CRO) regarding TMF matters and play a vital role in preparing for regulatory inspections and contributing to the review of departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs).

- Drive strategic collaboration with study managers and key functional areas to develop comprehensive eTMF plans for assigned studies, encompassing all aspects from transfer to migration and document listing.- Ensure the Trial Master File is rigorously maintained, always ready for audit and archival across multiple studies, upholding the highest standards of clinical documentation.- Expertly generate and distribute vital eTMF reports to stakeholders, providing insights into document quality control and eTMF system health, thus facilitating informed decision-making.- Conduct meticulous Quality Checks on document content, asserting the precision and completeness of the eTMF, and stand as the go-to subject matter expert for eTMF within study teams.- Identify and analyze eTMF trends to enhance training programs, create influential presentations and tools to uplift document quality, and contribute to the professional growth of Clinical Operations Interns through dedicated mentoring.

- Deliver expert administrative and strategic support for Trial Master Files (TMF) throughout study execution, closure, and archival phases, managing both electronic and traditional paper records with exceptional efficiency.- Formatted, upload, and authorized critical documents in the eDocs system, ensuring compliance and precision for regulatory submissions and Clinical Study Reports.- Innovate the creation of comprehensive Lists and Descriptions of Investigators, enhancing the clarity and utility of Clinical Study Reports.- Conduct rigorous review and Quality Control in the Vault eTMF system, guaranteeing document accuracy and compliance with regulatory standards.- Spearhead the creation and dissemination of Electronic Investigator Site Files, streamlining the process for multiple studies and improving accessibility for study teams.

- Proactively identify and mobilize skilled nursing resources for home health visits, enhancing clinical trial support and patient experience.- Develop and deliver comprehensive training to service providers, ensuring adherence to study protocol and excellence in home visit procedures.- Create and refine source documents to be completed by nursing staff to guarantee the highest standards before site implementation, as well as perform meticulous quality checks post visits to ensure accuracy and regulatory standards are met.- Manage and update study trackers, extracting critical content and metrics to evaluate study progression and key performance indicators effectively.- Engage in Sponsor and internal team discussions, distill essential minutes and action items, and streamline communication for project alignment. Additionally, manage the preparation and distribution of laboratory kits to service providers in accordance with study protocols and maintain active communication with study sites for new enrollments and ongoing participant involvement.

Deerfield, Il

- Complete online ACRP courses - Attend webinars with current employees to learn about drug development, ICH-GCP, and clinical trial management- Shadow current CRAs on interim monitoring visits and a site initiation visit.