Axle Informatics

NIH-NIAID-DMID-Clinical Advisor

Job Locations US-MD-Rockville
Posted Date 3 weeks ago(4/13/2021 5:52 PM)
ID
2021-1899
# 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 Microbiology and Infectious Diseases (DMID), Office of Regulatory Affairs (ORA) in Rockville, MD.

Responsibilities

  • Serve as the subject matter expert on matters related to pharmacy practice, investigational and commercial clinical trial material, drug information and medication use processes and procedures.
  • Serve as pharmacy liaison in the development/review of protocols and other study related documents with an emphasis on the investigational product related sections.
  • Liaise with the Division Programmatic Branches, protocol team, Principal Investigator (PI), and other site personnel in Manual of Procedure (MOP) development, and when necessary, train site personnel on proper mixing/dispensing procedures.
  • Liaise with manufacturers to resolve temperature excursions and stability issues.
  • Work with DMID contractors and subcontractors to facilitate investigational product review and management.
  • Assist in the coordination and development all pharmacy-related activities, projects and tasks within the DMID Product Support Team as defined by the Director of the Office of Regulatory Affairs.
  • Attend and contribute to interdisciplinary team meetings relating to clinical trials.
  • Maintain and update the DMID Study Product Management Guidelines to ensure compliance with all applicable regulations.

Experience Required / Requirements

  • Requires a Bachelor of Science in Pharmacy and/or Pharm.D.
  • Experience in clinical research, protocol development and conduct, clinical practice, pharmaceutical industry, home health and infusion and/or infectious diseases practice is required.
  • Minimum of three (3) years of related experience. Examples of desired experience include investigational drug related experience, drug manufacturing and clinical trial management experience.

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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