
Clinical Research Monitoring Expert
22 hours ago
At the forefront of clinical research, we are seeking a seasoned professional to assume a pivotal role in ensuring the seamless execution of trials.
This position requires an individual with exceptional monitoring expertise, who can effectively leverage their knowledge to drive quality and compliance across various studies.
A strong leader with excellent communication skills is essential to direct lower-level professionals, provide mentorship, and foster a collaborative environment.
Responsibilities- Clinical Research Monitoring: Conduct on-site and remote monitoring of clinical research studies to guarantee adherence to widely accepted clinical practices, including reviewing study protocols, case report forms, and regulatory documents
- Quality Assurance: Develop tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and standard operating procedures
- Process Improvement: Contribute to the design, implementation, and delivery of processes, programs, and policies by providing expert input and feedback during development and review stages
- Team Leadership: Direct the work of junior staff, oversee their monitoring activities, and ensure timely completion of tasks
- Regulatory Compliance: Ensure trials are conducted in accordance with regulatory requirements and company standards by performing regular audits and inspections, and addressing any compliance issues that arise
- Communication: Provide guidance and support to clinical research teams, including answering questions, resolving issues, and facilitating communication between team members and stakeholders
- Documentation: Maintain accurate and timely documentation of monitoring activities, including writing detailed monitoring reports, tracking study progress, and updating databases
- Troubleshooting: Identify and resolve issues related to clinical trial conduct, such as protocol deviations, data discrepancies, and adverse events, and implement corrective and preventive actions as needed
This critical role demands a strategic thinker with the ability to navigate complex challenges, build effective relationships, and drive results-driven solutions.
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