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Clinical Advisor (Pharmacist)

Rockville, MD

(ID: 2024-8412)


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 Pharmaceutical Affairs Branch (PAB), Office of Clinical Site Oversight (OCSO), Division of AIDS (NIADS).

 

Technical Requirements:
 

  • Coordinates and oversees study products supply, packaging, distribution, and accountability for all domestic and international clinical trials supported by the Division.

  • Participates in the review, planning and implementation of clinical trials. This will include the evaluation of study design, feasibility, pharmaceutical regulatory requirements, and identifying solutions for pharmaceutical and logistical problems that may impede the conduct of a study.

  • Develop the study intervention section of the protocols in cooperation with members of the protocol team and the pharmaceutical manufacturers for existing pharmaceutical products as well as new chemical entities and modalities. This includes researching and analyzing background material from Investigator’s Brochures, prescribing information, and literature reviews.

  • Oversees quality assurance standards and standard operating procedures for all pharmacy and product issues.

  • Advises Branch management of merits and deficiencies in proposed studies.

  • Assist with development of protocol specific trainings for site pharmacists and clinic staff utilizing web-based systems, software or other tools.

  • Create and review Operations and Study Specific Procedures manuals with leadership.

  • Ensure that pharmaceutical concerns raised during the Scientific Review Committee meetings and by the Regulatory Support Contract are addressed in a timely manner.

  • Advise the protocol team regarding pharmaceutical issues relating to DAIDS standards, FDA regulations and in-country requirements.

  • Evaluate the protocol and provide leadership with estimates of study product needs based on factors such as sample size, dose, formulation, strength, rate of accrual, and duration.

  • Perform calculations for study product dilutions and aliquots and for compounding pharmaceutical preparations.

  • Draft Study Product Request Letter for leadership’s review and final signature. These letters are the official letters of request from DAIDS to pharmaceutical companies.

  • Provide pharmaceutical expertise during protocol conduct on pharmacy queries, product management issues, product availability and appropriate recommendations.

  • Provide professional and technical assistance to pharmacists, study coordinators, investigators as well as domestic and international site personnel on a variety of topics, including protocols, study product preparation and dispensing information.

  • Collaborate with protocol teams regarding communications and letters to site pharmacists during the entire conduct of a protocol.

  • Conduct site visits to obtain information and create reports for federal staff to use to evaluate pharmacy personnel and infrastructure capacity at Clinical Research Sites.

  • Establish standards for clinical site pharmacies, reviews and approves pharmacy plans required for the establishment of all clinical sites that participate in trials sponsored by DAIDS and other collaborators.

  • Review Pharmacy Establishment Plans which include continuous communication with the site Pharmacist of Record to obtain information and clarity needed for final review and approval.

  • Utilize pharmacy practice experience and pharmaceutical expertise in the review and revision of PAB and DAIDS documents.

  • Participate in NIAID funded clinical network meetings, face-to-face protocol development meetings, and protocol team meetings as a pharmaceutical subject matter expert.

  • Review pharmacy monitoring assessment reports and provide input regarding pharmacy and protocol prioritization for Clinical Site Monitoring (CSM)

  • Contribute and edit scientific papers reporting results of research protocols for publication in scientific journals.

  • Perform other assignments as required.

 

Specific Qualifications:

 

  • Pharm.D. or B.S. degree from an accredited pharmacy school is required.

  • Licensed/registered as a pharmacist in a U.S. state or territory.

  • Completion of General Pharmacy Practice Residency or Specialized Residency or Fellowship plus 1 year of clinical research experience or 3 years of hospital pharmacy practice.

  • Knowledge or proficiency with the implementation or utilization of USP Guidance Chapters (795), (797), and (800).

  • Knowledge of Good Pharmacy Practice, Good Clinical Practice, and Human Subjects Protection

  • Excellent math skills in order to perform pharmaceutical calculations.

  • Ability to work independently and display self-motivation in all aspects of work

  • Ability to function effectively and work diplomatically as part of a team.


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.

Salary Range

$120,000 - $145,000 USD

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