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Clinical Advisor

(ID: 2024-8440)

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).

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 Clinical Research (DCR), Collaborative Clinical Research Branch (CCRB), Science Section (SS).

 

Technical Requirements:
 

  • Develop and adhere to relevant SOPs and pharmacy manuals.

  • Review investigator brochures and conduct literature searches if needed to serve as subject
    matter expert regarding investigational products in ongoing research protocols.

  • Oversee training and mentoring of staff.

  • Manage the quality control, completion and submission of study related documentation.

  • Prepare, submit and maintain Institutional Review Board (IRB), FDA, and/or other regulatory
    documents and research correspondence as needed.

  • Monitor protocol compliance.

  • Perform clinical data interpretation and data entry as needed.

  • Answer questions regarding sterile compounding of investigational products.

  • Establish cold-chain plans for transportation and storage of investigational products.

  • Evaluate site pharmacies and give recommendations on their ability to meet protocol
    requirements for investigational product handling, storage, preparation, and dispensing.

 

Specific Qualifications:

 

  • Pharm.D. or B.S. pharmacist (prior to 1992).

  • Minimum of at least three (3) years of clinical research experience is required.

  • Licensed to practice pharmacy in one of the US States or Territories.

  • Completion of Good Clinical Practice (GCP) and Human Subjects Protection training and
    experience working in a GCP setting.

  • Experience with FDA 21 CFR 312 regulations.

  • Experience in a pharmacy practice setting working with sterile products and cold-chain of
    products.

  • Experience in clinical research setting with protocols and clinical trials.

  • Strong writing and recordkeeping skills.

  • Knowledge of the roles and responsibilities of an investigational drug research pharmacist.

  • Licensing and Certification Requirements: The vendor must ensure that contract staff possesses and maintains/renews the appropriate licensure and/or certification as required by applicable law for the service being performed.

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.

 

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Salary Range
$135,000—$145,000 USD