Clinical Trials Specialist Jobs

Axle Informatics 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 highly ambitious, adaptable, structured, and detail-oriented Clinical Trials Specialist to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute on Aging (NIA) located in Bethesda, MD.

Overall Position Summary and Objectives BSR seeks a candidate to provide clinical trials stewardship and support, including assessment of policy compliance, risk assessment and appropriate level of oversight for NIA grant applications pre- and post- award. Activities includes conducting reviews of expertise and conflict of interest for NIA-appointed clinical trials oversight entities, providing administrative management and tracking of clinical trials, and developing and updating clinical trials oversight related standard operating procedures to comply with updated NIH and NIA guidance and policies. The position also provides guidance to BSR staff and applicants on compliance of clinical trials with NIH and NIA policies and updating BSR's clinical trials website.

Deliverables

• Update BSR CTO Website to be current with exiting NIH/NIA CT policies/guidelines. - Bi-Annually
• Conduct Risk Assessment of pending grant applications. - Weekly
• Review/evaluate expertise and COI information for prospective DSMB/Safety Officer nominees and communicate with relevant stakeholders regarding this evaluation. - Monthly
• Actively participate in CTO staff meetings. - Weekly
• Prepare 'Project Narratives' for pending grant applictions for use in quarterly Risk Assessment meetings. - Quarterly

Work Details

• Facilitate project management practice working groups and professional development sessions. 2
• Stay abreast of project management certification standards and industry principles through professional associations and implements practices. 4
• Coordinate, track and complete action items and report progress to project owners.
• Review other project management plans and recommend improvements. 1
• Update clinical trials website to aid applicants and grantees through the application and clinical trials implementation processes.
• Develops project management documentation.
• Perform literature reviews of related projects to identify new approaches to improving project management. 5
• Monitors and reports progress to project owners.
• Researches project management best practices and new industry standards.
• Conducts project analysis and reports to upper management.
• Creates project in designated project management software and ensure all necessary staff have access.
• Research new trends in project management and related project management software and applications to improve project management efficiency. 3
• Provide guidance to BSR staff and applicants on compliance of clinical trials with NIH and NIA policies.
• Recommend and support routine project management meetings, updates and prepare a variety of status reports and dashboards.
• Provides subject matter expertise and support to other project managers.
• Prepare progress reports, summaries, descriptions, and other materials to communicate with internal and external stakeholders.
• Develops and tracks project budgets.
• Assist staff coordinate project management activities, to include routine meetings and development of reports.
• Present project updates and status reports at recurrent staff and management meetings.
• Prepare project dashboards and summaries, milestone status and updates to work breakdown structure as necessary.
• Create and maintain comprehensive project documentation library using designated applications and tools.
• Measure project performance using designated systems, tools and techniques and report findings to upper management.
• Conduct project-related activities, including developing needed materials, power-point presentations, arranging discussions, and facilitating interactions.
• Develop summaries of project status and performance for review with upper management.

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

Minimum Education

Bachelor's

Additional Qualifications

Certifications & Licenses

• Good Clinical Practice Certification

Field of Study

• Clinical Psychology
• General Social Sciences

Software

• SharePoint
• MS Office

Skills

• Project management, website content management
• Meeting minutes/summary reports
• Outreach Activities
• Meeting coordination
• Data analysis

Benefits

• Dependent Care Assistant Program (DCAP)
• Profit Sharing
• 401K Matching
• Paid Time Off (Including Holidays)
• Healthcare (FSA)
• Transportation Reimbursement Account (TRN)
• Parking Reimbursement Account (PRK)
• Flexible Spending Accounts
• Educational Benefits for Career Growth
• Employee Referral Bonus
• 100% Medical Dental & Vision Coverage for Employees

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 [email protected]

DisclaimerThe above description is meant to illustrate the general nature of work and level of effort being performed by individual’s 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.