Clinical Trials Coordinator Jobs

• 100% Remote
• 11 Paid Federal Holidays / 9 Days PTO
• 4 -Year Contract
• Client is the National Institutes of Health, National Institute on Aging
• Medical, Dental, Vision, 401(k)
• 40/hrs a Week

POSITION INFORMATION

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.

Minimum Education

Bachelor's

Resume Max Pages

3

ADDITIONAL QUALIFICATIONS

Certifications & Licenses

• Project Management Professional (PMP)

Skills (Ranked By Priority)

1. Social Media, knowledge of the Federal Travel Regulation
2. Project management, website content management
3. Meeting minutes/summary reports
4. Meeting coordination
5. Outreach Activities
6. Data analysis

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

Software

• ITAS
• SharePoint
• MS Office

Field of Study

• Interdisciplinary Social Sciences

DELIVERABLES

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

STATEMENT OF WORK DETAILS

Develops project management documentation.

• Support Data and Safety Monitoring activities across the division.
• Coordinate compliance and oversight for clinical trials in BSR’s Center and Network programs.
• 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.

Monitors and reports progress to project owners.

• Prepare project dashboards and summaries, milestone status and updates to work breakdown structure as necessary.
• Coordinate, track and complete action items and report progress to project owners.
• Promote the NIH Stage Model for use in clinical trials research.
• Conduct project-related activities, including developing needed materials, power-point presentations, arranging discussions, and facilitating interactions.
• Provide guidance to BSR staff and applicants on rigorous clinical trials methodology grounded in behavioral and social science principles.

Conducts project analysis and reports to upper management.

• Create and maintain comprehensive project documentation library using designated applications and tools.
• 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.
• Present project updates and status reports at recurrent staff and management meetings.
• Prepare progress reports, summaries, descriptions, and other materials to communicate with internal and external stakeholders.

Develops and tracks project budgets.

• Assist Program Staff, PI/Team and others with monitoring DSMB activity.
• Assist with oversight of CTs, in particular those that include DSMB or Safety Officer monitoring.
• Communicate and troubleshoot potential areas of DSMB or CT concerns among all stakeholders.
• Provide advice in regulatory and data/safety monitoring oversight of clinical trials.
• Track and support the efficient operations of approximately 90 DSMBs across the division.

Researches project management best practices and new industry standards.

• Stay abreast of project management certification standards and industry principles through professional associations and implements practices.
• Research new trends in project management and related project management software and applications to improve project management efficiency.

Provides subject matter expertise and support to other project managers.

• Provide researchers and non-project staff presentations on appropriate project management practices.
• Identify and recommend project management professional development opportunities for other project managers and project support staff.