Clinical Research Coordinator

(ID: 2026-1830)

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 Research 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)

Position Information:

 

Provide support services to satisfy the overall operational objectives of the National Institutes of Health (NIH), National Institute on Aging (NIA). The primary objective is to provide services and deliverables through performance of support services.

 

 

 

Deliverables:

• Work products and documents related to providing lists of applications approved for award that are classified as Clinical Trials (CTs) Ad-HocWork products and documents related to providing lists of CT applications that require risk assessment - Ad-Hoc

• Work products and documents related to providing lists of CT applications that meet NIA criteria requiring a Data and Safety Monitoring Board (DSMB) - Ad-Hoc

• Work products and documents related to completed checklists used to review DSMBs - Ad-Hoc

• Work products and documents related to track receipt of DSMB signed Conflict of Interest and Confidentiality statements and required DSMB materials Ad-Hoc

• Work products and documents related to tracking documents showing status of stages of compliance - Ad-Hoc

• Work products and documents related to lists of coded adverse events - Ad-Hoc

• Work products and documents related to draft emails and memos and minutes of DSMB meetings and BSR communications. - Ad-Hoc

 

Statement of Work Details:

• Provide administrative and management support of experimental studies with human subjects and the appropriate conduct of behavioral interventions on individuals, communities, and populations for applications identified by NIA staff as being considered for award - 1
• Review and Identify suitable applications for award to be classified as Clinical Trial CT, working to ensure all approved applications are correctly specified - 2
• Report findings of CT applications, by developing summary statements to identify Human Subjects Concerns and request any necessary corrections from the applicant via email - 3
• Work with Clinical Trial Coordinator CTC to advise applicants that Authorized Organizational Representative AOR concurrence is required on responses - 4
• Review and Identify suitable applications for award to be classified as Clinical TrialCT, working to ensure all approved applications are correctly specified - 5

• Supports clinical staff develop, implement and maintain clinical research data files and materials.

• Report findings of CT applications, by developing summary statements to identify Human Subjects Concerns and request any necessary corrections from the applicant via email

• Work with Clinical Trial Coordinator CTC to advise applicants that Authorized Organizational Representative AOR concurrence is required on responses

• Identify applications that meet the NIA criteria requiring a Data and Safety Monitoring Board DSMB

• For CT applications that require a DSMB, work with CTC to inform applicant via email of NIH and NIA policies for clinical trials, attach relevant, current templates and request all appropriate information, with AOR concurrence required in response; which include but not limited to Data and Safety Monitoring Plan DSMP, Information on DSMB including membership contact i