Clinical Trial Coordinator
3 semanas atrás
We are seeking a dedicated and detail-oriented Clinical Trial Coordinator to join our hospital’s research team in São Paulo. This role is pivotal in managing and executing clinical trials in compliance with regulatory standards, ensuring the highest quality of patient care and data integrity.
Key Responsibilities
- Coordinate all aspects of clinical trial operations from initiation to close-out
- Liaise with investigators, sponsors, and regulatory bodies to ensure protocol adherence
- Recruit, screen, and enroll study participants in accordance with inclusion/exclusion criteria
- Maintain accurate and up-to-date trial documentation, including case report forms and source data
- Monitor patient safety and report adverse events promptly
- Schedule and conduct study visits, ensuring compliance with Good Clinical Practice (GCP)
- Assist in budget planning and resource allocation for clinical studies
- Train and supervise research assistants and support staff
- Prepare for and participate in audits and inspections
Qualifications
- Bachelor’s degree in life sciences, nursing, pharmacy, or related field (Master’s preferred)
- Several years of experience coordinating clinical trials
- Strong knowledge of ICH-GCP, ANVISA regulations, and international clinical research standards
- Excellent organizational and communication skills
- Proficiency in Portuguese and English (written and spoken)
- Familiarity with electronic data capture systems and trial management software
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