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Experienced Clinical Research Associate
Sin especificarTiempo completoClinical Research OperationsLife Scienceshealthcare
Conduct site monitoring and study management activities to ensure clinical trials meet protocol, regulatory, Good Clinical Practice, and sponsor requirements.
Responsabilidades
- Conduct site selection, initiation, monitoring, and close-out visits
- Monitor site compliance with study protocols, regulations, GCP, ICH guidelines, and sponsor requirements
- Support subject recruitment planning and track recruitment and enrollment progress
- Deliver protocol and study training to assigned sites
- Manage regulatory submissions, approvals, case report forms, and data queries
- Review site practices and escalate quality or compliance issues
- Maintain Trial Master File and Investigator Site File documentation
- Prepare monitoring reports, follow-up letters, action plans, and other study documentation
- Coordinate with study team members to support project execution
- Manage site financial activities and invoices when required
Requisitos
- At least 2 years of on-site clinical monitoring experience
- Knowledge of clinical research regulations, Good Clinical Practice, and ICH guidelines
- Knowledge of clinical trial protocols and therapeutic areas
- Proficiency with Microsoft Word, Excel, and PowerPoint
- Good written and verbal English communication skills
- Strong organizational, problem-solving, time-management, and financial-management skills
- High school diploma or equivalent; relevant education may be preferred or substituted with equivalent training and experience
Se valora
- Degree in a scientific or healthcare discipline
- Experience supporting study start-up activities
- Experience with site financial management