
Clinical Research Monitor Specialist
2 days ago
Our company is a leading provider of clinical research services. We are dedicated to accelerating customer success through the delivery of high-quality solutions.
Our clinical development model brings patients and customers to the forefront of everything we do. We strive to simplify and streamline our work to make our company easier to work with, and easier to work for.
We are passionate about developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
Key Responsibilities:- Conduct comprehensive on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices and study protocols
- Develop and implement tools, procedures, and processes to ensure quality monitoring and adherence to regulatory requirements
- Assist in the design, implementation, and delivery of processes, programs, and policies related to clinical monitoring, ensuring alignment with organizational goals
- Collaborate with study teams to ensure accurate and timely data collection, entry, and reporting, addressing any discrepancies or issues promptly
- Provide guidance and support to lower-level professionals, including training and mentoring, to ensure consistent application of monitoring practices
- Manage processes and programs as needed, ensuring efficient and effective operations within the clinical monitoring function
- Ensure the integrity and quality of clinical data through regular audits, reviews, and verification of source documents and data entries
- Maintain thorough and accurate documentation of monitoring activities, findings, and corrective actions, ensuring compliance with regulatory and organizational standards
- Communicate effectively with study sites, investigators, and other stakeholders to address any issues or concerns related to study conduct and monitoring
- Stay current with industry trends, regulatory changes, and best practices in clinical research and monitoring, incorporating new knowledge into daily practices
- Bachelor's degree in a relevant field such as life sciences, nursing, or a related discipline
- Previous experience in clinical research or a related field is preferred
- Strong understanding of clinical trial processes and regulations
- Excellent organizational and time management skills
- Ability to work independently and as part of a team
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