Isabel Trejos, PharmD, MSc, has more than 19 years of experience leading the full trial life cycle for domestic and global multicenter clinical trials and observational studies. She serves as the Project Director for the NICHD International and Domestic Pediatric and Perinatal HIV Studies Coordinating Center and manages several teams, including vendors and consultants, in multicultural, global, and cross-functional environments to deliver high-quality results, overcome challenges, and respond with effective solutions to NICHD and stakeholders. Trejos oversees services provided for study implementation, including but not limited to protocol development, regulatory, site preparation and operational assistance (e.g., development of study materials and training), vendor management, data management, monitoring visits, laboratory, GCLP training, clinical supplies and pharmacy services, data analysis, and administrative and programmatic support.
Trejos has ample experience enhancing and developing capabilities for sites with limited experience in research, resource-limited settings, and/or in remote locations for studies of children, adolescents, pregnant women, people living with HIV/AIDS, and other vulnerable populations. Her larger focus of expertise is phases 2 and 3 (vaccines and therapeutics), HIV, and global emerging infectious diseases, including respiratory diseases and the Zika virus. She is bilingual in English and Spanish.
During her role as a Project Manager for Clinical Research Support Services (CRSS), she conducted multiple site and pharmacy assessment visits in Africa, Asia, and Latin America in preparation for sites to conduct DAIDS clinical trials. She managed task orders with vendors to conduct for-cause and process GCP audits, domestic and international mock inspections for different DAIDS networks, and training for inspection preparation. Her experience also includes more than 10 years as the Project Manager for the Mexico Infectious Diseases Clinical Research Network (La Red) for NIAID’s Division of Clinical Research, with focus on respiratory and arbovirus emerging diseases.
- PharmD, Universidad de Costa Rica
- MSc, Instituto Centroamericano de Administración Pública (ICAP), Gerencia de la Salud (Health Management)