Clinical Research Pharmacist

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 individual to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS) Pharmaceutical Affairs Branch, Office of Clinical Site Oversight.
Responsibilities

• Coordinate and oversee study products supply, packaging, distribution and accountability for all domestic and international clinical trials supported by the Division.
• Participate 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, literature reviews, or other technical data.
• Oversee and manage quality assurance standards and standard operating procedures for all pharmacy and study product issues.
• Advise Branch leadership of merits and deficiencies in proposed studies.
• Develop protocol specific trainings for site pharmacists and clinic staff utilizing web based systems, software or other tools.
• Write and review Operations and Study Specific Procedures manuals.
• 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 Division standards, FDA regulations and in-country requirements.
• Evaluate the protocol and provide Branch 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.
• Generate Study Product Request Letter for Branch leadership’s review and final signature. These letters are the official letters of from the Division to pharmaceutical companies that describes the study product quantity estimates required for the implementation and completion of a clinical protocol.
• 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 pharmacy and study product related topics, including study product management, handling, 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 the Division and other collaborators.
• Review Pharmacy Establishment Plans which includes continuous communication with the site Pharmacist to obtain information and clarity needed for final review and approval.
• Utilize pharmacy practice experience and pharmaceutical expertise in the review and revision of Branch and Division documents.
• Participate in NIAID funded clinical network meetings, face-to-face protocol development meetings, and protocol team meetings as a pharmaceutical subject matter expert.
• Attend and participate in U.S./Non-U.S scientific meetings/conferences and national meetings of professional societies and organizations.
• 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.

Experience Required / Requirements

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

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:
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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