Axle Informatics

NIH-NIAID-DAIDS-Clinical Advisor

Job Locations US-MD-Rockville
Posted Date 2 weeks ago(2/10/2021 4:44 PM)
ID
2021-1816
# of Openings
1
Category
Other

Overview

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 around the globe. 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).

 

Overview

Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Advisor to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS), Office for Policy in Clinical Research Operations (OPCRO), Regulatory Affairs Branch (RAB), Rockville, MD.

Responsibilities

  • Assist with the development, implementation, and maintenance of the DAIDS Trial Master Files (TMFs) to meet regulatory requirements.
  • Provide support and guidance to various functional areas supporting the TMFs, both electronic and paper.
  • Provide support to DAIDS TMF operations during eTMF implementation, audits, and/or regulatory inspections.
  • Ensure TMF’s are “inspection ready” at all times and TMF documents are filed contemporaneously in a timely manner.
  • Monitor and identify study trends, communicate issues, and escalate concerns to the federal client.
  • Liaise with Regulatory, Quality, and other task area leads to reconcile TMF documents, which have been received from various functional areas to ensure completeness and quality of files.
  • Ensure compliance with ICH, US federal regulations, and DAIDS policies and procedures.
  • Assist in the tracking of all TMF activities (essential document submission and status).
  • Participate in working groups and team meetings.
  • Develop SOPs to ensure oversight of the DAIDS TMF process.

Benefits

  • 100% Medical, Dental & Vision premium coverage for Employees
  • Paid Time Off (Including Holidays)
  • Employee Referral Bonus
  • 401K Match
  • Tuition reimbursement and professional development opportunities
  • Flexible Spending Accounts:
    • Healthcare (FSA)
    • Parking Reimbursement Account (PRK)
    • Dependent Care Assistant Program (DCAP)
    • Transportation Reimbursement Account (TRN)

 

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 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: careers@axleinfo.com

 

Disclaimer: The 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.

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