Full-Time
Clinical Trials Coordinator
Posted on 7/23/2024
Axle
201-500 employees
Provides informatics solutions for biomedical research
Junior
Bethesda, MD, USA
- Certifications & Licenses
- Field of Study
- Software
- Skills
- Meet with Office of Behavioral/Social Clinical Trials Staff to present updates
- Provide guidance to BSR staff regarding CT policies and procedures
- Provide summary of DSMB meeting activity and complete documentation for archive
- Assist CTO with quarterly risk assessment meetings and providing feedback to stakeholders regarding final risk assessment status
- Provide advice in regulatory and data/safety monitoring oversight of clinical trials
- Assist Program Staff, PI/Team and others with monitoring DSMB activity
- Track and support the efficient operations of approximately 90 DSMBs across the division
- Communicate and troubleshoot potential areas of DSMB or CT concerns among all stakeholders
- Assist with oversight of CTs, in particular those that include DSMB or Safety Officer monitoring
- Develop project management documentation
- Create project in designated project management software and ensure all necessary staff have access
- Recommend and support routine project management meetings, updates and prepare a variety of status reports and dashboards
- Assist staff coordinate project management activities, to include routine meetings and development of reports
- Support Data and Safety Monitoring activities across the division
- Coordinate compliance and oversight for clinical trials in BSR’s Center and Network programs
- Monitors and reports progress to project owners
- Conduct project-related activities, including developing needed materials, power-point presentations, arranging discussions, and facilitating interactions
- Coordinate, track and complete action items and report progress to project owners
- Prepare project dashboards and summaries, milestone status and updates to work breakdown structure as necessary
- Provide guidance to BSR staff and applicants on rigorous clinical trials methodology grounded in behavioral and social science principles
- Promote the NIH Stage Model for use in clinical trials research
- Conduct project analysis and reports to upper management
- Prepare progress reports, summaries, descriptions, and other materials to communicate with internal and external stakeholders
- Develop summaries of project status and performance for review with upper management
- Measure project performance using designated systems, tools and techniques and report findings to upper management
- Create and maintain comprehensive project documentation library using designated applications and tools
- Present project updates and status reports at recurrent staff and management meetings
- Develop and track project budgets
- Research project management best practices and new industry standards
- Research new trends in project management and related project management software and applications to improve project management efficiency
- Stay abreast of project management certification standards and industry principles through professional associations and implements practices
- Provide subject matter expertise and support to other project managers
- Identify and recommend project management professional development opportunities for other project managers and project support staff
- Provide researchers and non-project staff presentations on appropriate project management practices
Axle Informatics provides specialized solutions that combine bioscience and information technology, focusing on translational research, health informatics, and data science. Their products help research centers and healthcare organizations turn scientific discoveries into practical applications, such as new treatments or diagnostics. Axle develops research tools that enhance decision-making by utilizing advanced analytical models, algorithms, and visualization tools to manage large volumes of data. This automation allows researchers to efficiently track and analyze data, leading to improved healthcare outcomes. Unlike many competitors, Axle emphasizes customized software and data management platforms that help users extract quantitative insights from qualitative research data, facilitating the transition from laboratory research to clinical application. The company's goal is to advance public health by providing informatics solutions that support biomedical and clinical research.
Company Stage
N/A
Total Funding
N/A
Headquarters
Rockville, Maryland
Founded
N/A
6 month growth
↑ 11%1 year growth
↑ 11%2 year growth
↑ 11%
Simplify's Take
What believers are saying
- Collaborations with major institutions like NIH and NCI provide significant opportunities for impactful research and career growth.
- The company's focus on cutting-edge technology and advanced analytical models offers employees the chance to work on innovative projects that drive healthcare advancements.
- Axle's role in high-profile projects, such as the development of COVID-19 histopathology image collections, underscores its influence and potential for future growth.
What critics are saying
- The highly specialized nature of Axle's work may limit its market to niche segments, potentially constraining growth opportunities.
- Dependence on large-scale collaborations and government contracts could pose risks if such partnerships are not sustained.
What makes Axle unique
- Axle Informatics uniquely combines bioscience expertise with advanced IT solutions, specifically targeting translational research and health informatics, unlike competitors who may focus solely on one domain.
- Their ability to automate data aggregation and provide intuitive digital tools for large-scale data interpretation sets them apart in the biomedical research market.
- Axle's collaborative projects with high-profile institutions like the NIH and NCI highlight their credibility and specialized capabilities in the field.