Focused on early-phase neurodegenerative research, responsible for reviews focused on fluid, imaging and clinical outcomes. Work directly with senior members of the Kisbee Clinical Development team to synthesize literature and present data to drive informed decision-making for Phase I/II clinical trials through innovative therapeutic solutions.

Worked with members of the Alkeus team to support data management, maintenance of clinical trial files (eTMF), subject data processing, quality control per FDA and ICH GCP guidelines and analysis of data through statistical means. Was responsible for maintaining clinical trial files (eTMF), tracking, processing subject data (EDC) and coordinating with key stakeholders and labs to allow for data exchange. Assisted with clinical site agreements, reconciliation and tracking of purchase orders, invoices, and quality control for multiple ongoing clinical trials simultaneously. Acted as a liaison between various clinical research coordinators and key stakeholders as well as current and prospective study participants. Verified trial/study data, including maintaining appropriate regulatory documents for both internal and external auditing.

Reported to the Lead Clinical Research Associate, responsible for identifying and investigating discrepancies in study documentation by applying clinical protocol and GCP knowledge and developing processes to mitigate reoccurrence throughout study phases. Performed study start-up and conducted activities including ICF reviews that meet US regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities. Conducted reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, company internal SOPs, and US regulations. Assessed all data documentation for consistency with case report forms, and determined if clinical study subject documentation is within parameters of study hypotheses, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP, PHI and regulatory requirements.Worked alongside the Director of PHFI and Senior Principal Investigators on programs focusing on prevention and early intervention to improve health outcomes in rural populations under the guidance of Senior Public Health Specialists. Worked directly with the Director of IIPH and his team on USAID funded Retinopathy of Prematurity Project and Low Vision Project.

As an Undergraduate Research Associate in Biology & Ecology working for the Doyle Lab, developed, and performed research on the availability of biologically active carbon in pond communities based on Biological Oxygen Demand (BOD) data collected. Supported the lab as a Principal Investigator while researching, developing, creating, editing, and presenting this data as needed. Presented findings at multiple conferences and forums including Baylor University’s Undergraduate Research and Scholarly Achievement (URSA) conference.