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Site Monitoring Specialist
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Job Summary
We are seeking an experienced Sr. Cra 2 to manage and monitor clinical trials from initiation to close-out. The successful candidate will have strong therapeutic and protocol knowledge, excellent communication skills, and the ability to work effectively in a team environment.
Key Responsibilities:
- Manage and monitor clinical trials from initiation to close-out.
- Perform site monitoring visits to ensure compliance with contracted scope of work and regulatory requirements.
- Administer protocol and related study training to assigned sites and establish regular lines of communication.
- Evaluate the quality and integrity of study site practices and escalate quality issues as appropriate.
Requirements:
- Bachelor's Degree in a scientific discipline or healthcare preferred.
- At least 6 years of on-site monitoring experience.
- In-depth knowledge of applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Strong therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in Microsoft Word, Excel, and PowerPoint.
- Effective written and verbal communication skills, including good command of the English language.
- Organizational and problem-solving skills.
