RESPONSIBILITIES:
- Site Management: Manage all aspects of site activities, including site selection, initiation, monitoring, and close-out visits, ensuring adherence to protocol and regulatory requirements
- Remote Monitoring: Oversee and perform remote site management, ensuring data integrity, protocol compliance, and timely reporting
- Investigator Training: Train investigators and site staff on protocol, study objectives, and regulatory requirements
- Study Planning & Oversight: Develop study plans, including timelines, budgets, and resources, and ensure their alignment with project objectives
- Regulatory Documentation: Assist in the preparation, submission, and follow-up of regulatory documents, including IRB submissions, protocol amendments, and safety reporting
- Risk Management: Proactively identify potential risks and implement mitigation strategies to ensure smooth trial execution.
- Stakeholder Communication: Maintain clear and proactive communication with sponsors, investigators, and cross-functional teams to ensure alignment and resolve any issues promptly
- Data Integrity: Ensure that all site data and documentation are accurate, complete, and in compliance with Good Clinical Practice (GCP) and regulatory standards
- Close-out Activities: Oversee site close-out processes, ensuring all study-related documentation is reconciled and submitted on time
QUALIFICATIONS:
- Bachelor’s degree in Life Sciences, Clinical Research, or a related field
- 3+ years of experience in clinical research, with a focus on clinical trial management and site monitoring
- Strong knowledge of FDA regulations, ICH-GCP guidelines, and international clinical research requirements
- Proven ability to manage multiple sites and complex clinical trials, both remotely and on-site
- Excellent organizational skills, with the ability to manage timelines, budgets, and project deliverables
- Strong written and verbal communication skills, with the ability to collaborate across teams and manage stakeholders
- Experience with clinical trial management systems (CTMS) and electronic data capture (EDC) systems
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