Postdoctoral Fellow research role at Miami University's Center for Civics, Culture, and Society. Focusing on civic education, scholarship, and public program facilitation.
About the role
- Clinical Research Associate overseeing clinical trial sites at IQVIA Biotech. Ensure high-quality study execution and adherence to protocols and regulations.
Responsibilities
- Conduct site visits (selection, initiation, monitoring, and close-out) in compliance with GCP, ICH, and study requirements.
- Partner with sites to drive patient recruitment and meet study enrollment goals.
- Provide study protocol and procedure training to site staff and maintain consistent communication to support study progress.
- Assess site performance, data quality, and regulatory compliance; escalate issues when needed.
- Track study milestones including submissions, approvals, enrollment, data entry, and query resolution.
- Ensure accurate and complete maintenance of site documentation and Trial Master File materials.
- Prepare monitoring reports, follow-up letters, and other required documentation.
- Collaborate closely with the study team and provide support with start-up activities as applicable.
- (If applicable) Support site-level recruitment planning and financial management.
Requirements
- Bachelor’s degree in a scientific or healthcare field (or equivalent experience)
- Minimum 1 year of on-site clinical monitoring experience
- Strong knowledge of GCP/ICH guidelines and clinical research regulatory requirements
- Proficiency with Microsoft Office and digital tools (laptop, mobile devices)
- Excellent communication, organization, and problem-solving skills
- Ability to build strong working relationships with study teams, site staff, and sponsors.
Benefits
- incentive plans
- bonuses
- health and welfare benefits
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