Senior Clinical Operations Specialist
1 week ago
We are seeking a skilled Risk Based Monitoring Coordinator to join our team. The ideal candidate will have a strong background in clinical research monitoring and a proven track record of successfully implementing risk-based monitoring strategies. As a Risk Based Monitoring Coordinator, you will be responsible for developing and implementing risk-based monitoring plans, conducting remote or on-site visits to assess protocol and regulatory compliance, and managing required documentation.
About the Role:
This is an exciting opportunity to work with a global leader in the life sciences industry, and contribute to the success of clinical trials that are changing lives around the world. As a Risk Based Monitoring Coordinator, you will have the opportunity to work with a talented team of professionals, and develop your skills and expertise in risk-based monitoring. You will also have access to ongoing training and development opportunities, and be part of a company that values innovation, integrity, and excellence.
Key Responsibilities:
- Develop and implement risk-based monitoring plans
- Conduct remote or on-site visits to assess protocol and regulatory compliance
- Manage required documentation and ensure audit readiness
- Develop collaborative relationships with investigational sites
- Ensure data accuracy through SDR, SDV, and CRF review as applicable
Requirements:
To be successful in this role, you will require a Bachelor's degree in a life sciences-related field or a Registered Nursing certification, and at least 2 years of experience in clinical research monitoring. You will also need to possess excellent clinical monitoring skills, demonstrated understanding of medical/therapeutic area knowledge and medical terminology, and effective oral and written communication skills. Additionally, you will need to be able to manage risk-based monitoring concepts and processes, and have strong attention to detail.
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