Site Support Manager

(ID: 2024-6396)

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 Site Support Manager to join our vibrant team at the National Institutes of Health (NIH) supporting the Office of the Director (OD) 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)
  
  
  
  

Overall Position Summary and Objectives

Serve as a Subject Matter Expert on human subjects' protection regulation and IRB review for participating sites (awardees) and Principal Investigators (PIs). Serve as a lead reviewer of IRB site submissions to ensure compliance with applicable program policies, regulations, IRB determinations and program best practices.

Work Details:

• 
  

  Submit local site submissions to the IRB. 1 

  
  

• 
  

  Facilitate communication between the site and IRB during IRB review of site submissions including communicating with program and consortium stakeholders regarding IRB review processes and procedures and maintaining records of critical communications. 2 

  
  

• 
  Define problems; analyze alternatives; recommend solutions to complete problems affecting the conduct of research programs. 3
  


• Researches and evaluates the operation of the organization's scientific programs. 


• Work with staff on existing projects and/or the development, initiation and execution of new project initiatives. 


• Organize and maintain project documentation and communications; track project progress using project management tools. Review and proofread programmatic documents describing scientific and management issues and policies related to their designated program. 


• Track action items and tasks, provide deadline reminders to Program staff; maintain spreadsheets of relevant information. 


• Request information from and provide responses to principal investigators program staff and others on scientific and programmatic issues. 


• Research, interprets and summarizes background materials from a variety of scientific sources. 


• Organize and analyze reports in a scientific area as assigned. Compiles data and creates and prepares graphs, slides and presentations. 


• Prepare scientific and programmatic presentation materials such as tables, graphs, slides, abstracts, posters and overheads by assimilating and mastering the scientific data and programmatic context for use at presentations and meetings. 


• Analyze and develop presentations consisting of data from progress reports to be used by Program staff and at meetings in the overall analysis of Program progress. 


• Performs logistical planning of various scientific meetings, lectures, workshops. 


• Attend meetings, training and conferences in support of program initiatives. 


• Work with staff to identify key issues and track action items and tasks, providing deadline reminders to Program staff and update and maintain spreadsheets of relevant information. 


• Plans, organizes and participates at a senior level in technical meetings and consultations. 


• Maintain ongoing, proactive communication with key personnel throughout the initiative; gather, provide and exchange information with Network investigators, their staff and other relevant individuals. 


• Reviews and evaluates the performance of the organization. 


• Ensure that all aspects of the programs are tracked and reported, key milestones and deliverables dates are known and adhered to, and that all individuals and partners involved are kept appraised of progress of integrated tasks and next steps. 


• Analyzes existing scientific programs and makes recommendations for improvement. 


• Analyze program activities, via internal systems and/or NIH systems, to identify issues and develop recommendations for improvement. 


• Work with staff to assist and conduct management and administrative analysis; evaluate procedures, policies, processes and systems for the purpose of improving efficiency. 


• Coordinate and participate in the development, maintenance, modification, and finalization of SOPs for the management of All of Us site support effort. 


• Develop and implement template documents, forms, and other tools for site investigators that support compliance with Research Compliance Brance (RCB) site support SOPs.


• Develops and prepares various scientific reports.


• Organize, analyze, and write project reports, scientific papers and present reports in scientific areas, based on results and findings.


• Organize and maintain a repository of resources, including minutes, reports, spreadsheets and web pages related to the program.


• Complete progress reports that detail project status and flag potential issues. 


• Track project progress and provide regular reports. 


• Develops and implements new scientific programs in order to fulfill organizational goals and objectives. 


• Design, perform and complete research projects, applying scientific knowledge to each project, and provide a detailed summary of goals and scope, milestones and go/no go decisions points.

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

Minimum Education

Masters

Additional Qualifications:

Certifications & Licenses:

Certified Institutional Review Board (IRB) Professional (CIP) 

Field of Study:

Miscellaneous Biology 

Software:

• 
  

  Adobe Acrobat 

  
  


• 
  

  PowerPoint 

  
  


• 
  

  SharePoint 

  
  

Skills:

• 
  

  Reports 

  
  


• 
  

  Institutional Review Board (IRB) amendments and continuing reviews 

  
  


• 
  

  Institutional Review Board (IRB) submissions

  
  

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