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Clinical Advisor

Rockville, MD

(ID: 2025-0695)


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 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).


Benefits:

  • 100% Medical, Dental & Vision 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)

 

Overview

Axle is looking to add a driven, flexible, organized, and meticulous Clinical Advisor to our dynamic team. The Contractor(s) shall provide services in support of the overall functions of the Division of AIDS (DAIDS).

 

Requirements:

  • Provide human subject protections-related guidance on protocols and associated documents for DAIDS-supported human clinical research studies throughout the lifecycle of the protocol.

  • Conduct scientific and full regulatory reviews of clinical research protocols and provide advice on human subject protections-related aspects of the protocol under review.

  • Contribute to and participate in inspection preparedness activities.

  • Possess and maintain knowledge of pertinent human subject protections regulations and guidances, including Office for Human Research Protections (OHRP), Food and Drug Administration (FDA) regulations, ICH guidelines, and any other applicable laws, regulations, policies, and guidances.

  • Maintain up-to-date knowledge of NIH/NIAID/DAIDS policy and procedure changes related to human clinical trial participant safety.

  • Communicate new information related to human subject protections, policies, and procedures to the departmental Branch Chief, OPCRO leadership, and other DAIDS staff and stakeholders.

  • Participate in team calls, branch meetings and other meetings, as requested.

  • Provide status updates and recommendations to the departmental Branch Chief, such as, on resolution of issues, etc.

  • Develop briefings for the protocol team, departmental Branch Chief, OPCRO leadership and/or other DAIDS leadership, as requested.

 

Qualifications:

  • Minimum of a Master’s Degree and a least 3 years of relevant of experience years in the field of human subject protection and policy development.


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: 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.

This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate’s experience, qualifications, skills, and location.

#INDPSD

Salary Range

$90,000 - $110,000 USD

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