Clinical Trials Coordinator

(ID: 2024-5691)

Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).

Axle is seeking a Clinical Trials Coordinator to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute on Aging (NIA) located in Bethesda, MD.

Benefits We Offer

• 100% Medical, Dental & Vision Coverage for Employees
• Paid Time Off and Paid Holidays
• 401K match up to 5%
• Educational Benefits for Career Growth
• Employee Referral Bonus
• Flexible Spending Accounts:
• Healthcare (FSA)
• Parking Reimbursement Account (PRK)
• Dependent Care Assistant Program (DCAP)
• Transportation Reimbursement Account (TRN)
  

Summary

Overall Position Summary and Objectives

NIA’s Division of Behavioral and Social Research (BSR) supports clinical trials targeting social and behavioral processes relevant to aging and AD/ADRD at all stages of intervention development, ranging from experimental tests of the malleability of mechanisms of behavior change in controlled contexts to pragmatic trials in health systems to optimize delivery of care and services to older adults. BSR seeks a Clinical Trials Coordinator to support Data and Safety Monitoring for the division at large and to coordinate compliance and oversight for clinical trials in BSR’s Center and Network programs. We seek candidates with strong organizational, managerial and evaluation skills.

Deliverables

• Meet with Office of Behavioral/Social Clinical Trials Staff to present updates. - Weekly
• Provide guidance to BSR staff regarding CT policies and procedures. - Quarterly
• Provide summary of DSMB meeting activity and complete documentation for archive. - Bi-Weekly
• Assist CTO with quarterly risk assessment meetings and providing feedback to stakeholders regarding final risk assessment status. - Quarterly
  
  

Work Details

• Provide advice in regulatory and data/safety monitoring oversight of clinical trials. 1
• Assist Program Staff, PI/Team and others with monitoring DSMB activity. 2
• Track and support the efficient operations of approximately 90 DSMBs across the division. 3
• Communicate and troubleshoot potential areas of DSMB or CT concerns among all stakeholders. 4
• Assist with oversight of CTs, in particular those that include DSMB or Safety Officer monitoring. 5
• Develops project management documentation.
• Creates 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.
• Conducts 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.
• Develops and tracks project budgets.
• Researches 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.
• Provides 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.
  
  

1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked

Minimum Education

Additional Qualifications

Certifications & Licenses

• Project Management Professional (PMP)
  
  

Field of Study

• Interdisciplinary Social Sciences
  
  

Software

• SharePoint
• MS Office
• ITAS
  
  

Skills

• Social Media, knowledge of the Federal Travel Regulation
• Project management, website content management
• Meeting minutes/summary reports
• Meeting coordination
• Outreach Activities
• Data analysis
  
  

Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.

The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.

Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com