Raleigh, North Carolina, United States
Experienced clinical trial professional with a strong resume across all phases of Oncology clinical trials, from start-up to close-out and phases I-III. I bring a well-rounded background in program support, data management, and clinical trial operations, backed by a Bachelor of Science in Public Health with a minor in Emergency Management. My career is further enriched by professional clinical experience and international work with non-profit humanitarian organizations in Burundi Africa.
- Establishes and maintains the Trial Master File (eTMF) in inspection-ready state - Communicate with sites to drive collection and review of essential documents throughout the study - Establishes and maintains the Clinical Trial Management System (CTMS) - Maintains accurate and up-to-date site, vendor, and internal study team contact information - Assists with the creation and maintenance of documents and plans for assigned clinical studies, including but not limited to training materials, study binders, plans, presentations, and reports
Provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs), and all applicable guidelines and regulatory requirements (ICH-GCP), Good Pharmacoepidemiology practice, and country/region-specific regulations. Acts as primary point of contact for study sites.
• Coordinated all the logistical operations while in Burundi, Africa. • Recruited several medical professionals to accompany Empower for Hope in the mission trips to Burundi. • Set up a mobile medical clinic where I was able to treat and help over 400 people in need while in a remote part of Burundi, Africa. • Coordinated the fundraising efforts for Empower for Hope and raised over $50,000 that was needed to purchase land for a medical facility in Burundi. • Provided all necessary training and orientation for the missionaries that joined Empower for Hope in our trips.