Clinical Trials Coordinator
2 weeks ago
We are seeking a highly motivated Clinical Trials Coordinator to join our team at IQVIA. As a key member of our site management team, you will be responsible for ensuring the smooth execution of clinical trials. Your primary focus will be on site management, where you will work closely with research sites to ensure they are conducting studies in accordance with regulatory requirements and study protocols.
Main Responsibilities:- Conduct Site Monitoring Visits: Perform visits to research sites to assess their compliance with regulations and study protocols.
- Develop Subject Recruitment Plans: Collaborate with sites to develop and track subject recruitment plans to enhance predictability.
- Provide Training and Support: Provide protocol and related study training to assigned sites, establish regular lines of communication, and manage ongoing project expectations and issues.
- Evaluate Study Sites: Assess the quality and integrity of study site practices, identify areas for improvement, and escalate quality issues as necessary.
- Track Study Progress: Monitor regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, and data query generation and resolution.
Requirements:
- Education: Bachelor's degree in a scientific discipline or healthcare preferred.
- Experience: At least 1 year of on-site monitoring experience required.
- Clinical Research Knowledge: Good knowledge of applicable clinical research regulatory requirements, including GCP and ICH guidelines.
- Communication Skills: Excellent written and verbal communication skills, including proficiency in English.
- Organizational Skills: Strong organizational and problem-solving skills, with ability to prioritize tasks and manage multiple projects simultaneously.
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