Initiation Clinical Research Associate - iCRA
Primary Location: Brazil, Remote Additional Locations: Colombia, Remote; Mexico, Remote ID de la oferta R0000045120 Categoría Clinical Trials Fecha de publicación 08/25/2026Overview
Como Auxiliar de investigación clínica (CRA) en Parexel, usted cumple una función vital para hacerles llegar los tratamientos a los pacientes con mayor rapidez. La prioridad de nuestros CRA es la seguridad y el bienestar de los pacientes. Cuando viaje a centros de investigación y cumpla sus obligaciones de monitoreo, lo alentamos a ser inquisitivo, a asumir responsabilidades, a construir relaciones y a actuar con integridad.
Únase a un equipo con una gran variedad de experiencias y conocimientos y trabaje en proyectos globales dentro de una amplia gama de áreas terapéuticas. Estamos buscando personas que deseen crecer en el ámbito personal y profesional y que respalden a sus colegas de manera global y multidisciplinaria.
Perfil del éxito
¿Posee estas competencias sociales y rasgos interpersonales para tener éxito en Parexel?
- Comunicador
- Organizado
- Contratos laborales flexibles
- Emprendedor
- Orientado al detalle
- Solucionador de problemas
Acerca de este rol
The Initiation Clinical Research Associate (iCRA) is responsible for leading and executing all study start-up, pre-SIV, activation, and protocol amendment activities from site identification through site activation and maintenance. Acting as the primary contact for assigned sites, the iCRA manages regulatory submissions, site readiness, document quality, and activation timelines while ensuring compliance with sponsor, regulatory, and company requirements.
Key responsibilities include:
- Managing site start-up activities from feasibility and qualification through activation.
- Building strong relationships with investigators and site staff.
- Preparing, reviewing, negotiating, and executing regulatory and site documents, including CDAs, ICFs, translations, and amendments.
- Coordinating submissions and approvals with IRBs/IECs, Ministries of Health, and Regulatory Authorities.
- Developing and tracking activation strategies, timelines, and regulatory plans.
- Maintaining high-quality documentation in CTMS, eTMF, and TMF systems, ensuring First Time Quality (FTQ).
- Identifying, resolving, or escalating site issues and risks related to activation, recruitment, compliance, training, and data quality.
- Supporting sites with study system access, training requirements, and readiness activities.
- Ensuring sites remain audit- and inspection-ready throughout the study lifecycle.
- Maintaining compliance with ICH-GCP guidelines, local regulations, sponsor requirements, and Parexel SOPs.
- Collaborating cross-functionally to achieve project milestones and deliverables while proactively communicating progress, risks, and issues.
Required Skills and Experience:
- Strong clinical research and study start-up experience.
- Excellent problem-solving, communication, presentation, and stakeholder management skills.
- Ability to work independently, prioritize multiple tasks, and make decisions in ambiguous situations.
- Strong knowledge of CTMS, eTMF, TMF, and Microsoft Office tools.
- Experience working in global, matrix, and multicultural environments.
- High attention to detail, quality focus, and commitment to achieving project timelines.
- Excellent English skills (oral and written).
Education: Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or another health-related field (or equivalent experience) is preferred.
#LI-REMOTE
POTENCIAL TRAYECTORIA PROFESIONAL
Parexel ofrece diversas trayectorias profesionales y programas de desarrollo interno para que los CRA avancen al próximo nivel. Esto podría incluir mejorar su puesto técnico, transferencia a gerencia o cambiar a otras áreas del negocio.
- APEX CRA
- CRA I
- CRA II
- CRA Sénior
- Gestión de ProyectosExperto en la MateriaGestión de Proyectos
Perspectivas de los empleados
nuestro equipo
POR QUÉ TRABAJAR EN PAREXEL
