Clinical Research Associate - FSP
Czechia, Remote ID de la oferta R0000022269 Categoría Clinical Trials Fecha de publicación 04/18/2024Overview
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
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Position Purpose:
The Clinical Research Associate (CRA) will act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Primary Duties:
Develops strong site relationships and ensures continuity of site relationships through all phasesof the trial
Performs clinical study site management/monitoring activities in compliance with ICH-GCP,
Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associateddocuments
Gains an in-depth understanding of the study protocol and related procedures
Coordinates & manages various tasks in collaboration with other sponsor roles to achieve SiteReady
Participates & provides inputs on site selection and validation activities
Performs remote and on-site monitoring & oversight activities using various tools to ensure:
- Data generated at site are complete, accurate and unbiased
- Subjects’ right, safety and well-being are protected
Conducts site visits including but not limited to validation visits, initiation visits, monitoringvisits, close-out visits and records clear, comprehensive, and accurate visit & non-visit contactreports appropriately in a timely manner
Collects, reviews, and monitors required regulatory documentation for study start-up, studymaintenance and study close-out
Communicates with Investigators and site staff on issues related to protocol conduct,recruitment, retention, protocol deviations, regulatory documentation, site audits/inspectionsand overall site performance
Identifies, assesses, and resolves site performance, quality or compliance problems and escalatesper defined CRA Escalation Pathway as appropriate in collaboration with Clinical Research Associate-Manager (CRAM)/Clinical Research Manager (CRM), Partner Line Manager (PLM)
Manages and maintains information and documentation in CTMS, eTMF and various othersystems as appropriate and per timelines
Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required
Supports and/or leads audits/inspection activities as needed
Performs co-monitoring visits where appropriate
Experience or ability to support and/or lead audit/inspection activities as needed
Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training
Adheres to EP and Client SOPs and processes
Skills and Education:
B.A./B.S. preferred with a strong emphasis in science and /or biology
Minimum 2 years of direct site management (monitoring) experience in bio/pharma/CROrequired
Note: No compromise on minimum monitoring experience however specific monitoring and therapeutic area experience requirements may vary depending on the Country or study needs
Fluent in local languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively
Good understanding and working knowledge of clinical research, phases of clinical trials, currentGCP/ICH & country clinical research law & guidelines.
Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to workwithin these guidelines
Hands on knowledge of Good Documentation Practices
Proven skills in Site Management including management of site performance and patientrecruitment
Demonstrated high level of monitoring skill with independent professional judgement
Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet andmobile devices) and ability to adapt to new IT applications on various devices
Ability to understand and analyze data/metrics and act appropriately
Capable of managing complex issues, working solution – oriented
Performs root cause analysis and implements preventative and corrective action
Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
Demonstrated high level of monitoring skill with independent professional judgement
Able to work highly independently across multiple protocols, sites, and therapy areas
High sense of accountability / urgency
Ability to set priorities and handle multiple tasks simultaneously in a changing environment
Works effectively in a matrix multicultural environment
Ability to establish and maintainculturally sensitive working relationships.
Demonstrates commitment to Customer focus
Works with high quality and compliance mindset
Positive mindset, growth mindset, capable of working independently and being self-driven
Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices
Ability to travel domestically and internationally approximately 65%-75% of working time.
Expected travelling ~2-3 days/week
Current driver’s license required
#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
