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Experienced Clinical Research Associate
Not specifiedFull-timeClinical Research OperationsLife Scienceshealthcare
Conduct site monitoring and study management activities to ensure clinical trials meet protocol, regulatory, Good Clinical Practice, and sponsor requirements.
Responsibilities
- 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
Requirements
- 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
Nice to have
- Degree in a scientific or healthcare discipline
- Experience supporting study start-up activities
- Experience with site financial management