Clinical Operations Coordinator

4 weeks ago

Bethesda, United States Axle Full time
Job DescriptionJob Description

(ID: 2024-5199)

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 seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Operations Coordinator to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Pharmaceutical Affairs Branch (PAB) in the Office of Clinical Site Oversight, Division of AIDS (DAIDS).

Technical Requirements:

  • Independently work with pharmacists in the development and/or review of pharmacy specific documents (e.g. Pharmacy Establishment Plans) and standard operating procedures of relevance to Branch activities.
  • Independently create and maintain a variety of electronic databases for all clinical research site pharmacy information and activities.
  • Serve as an information resource on use of SharePoint applications and point of contact for resolving user problems.
  • Independently create quarterly monitoring assignments based on pharmacy and protocol prioritization at clinical research sites for clinical site monitoring.
  • Review site pharmacy monitoring reports and use the NIAID web-based clinical site monitoring system to address any issues noted with the site pharmacist until resolution.
  • Create and track pharmacy special monitoring assignments.
  • Manage a portfolio of sites in collaboration with a PAB Site pharmacist.
  • Participate in site visits, as needed, to evaluate the facility, equipment, pharmacy personnel, and infrastructure capacity and provide report to PAB federal client.
  • Create work flow and project management tools to track key milestones and/or identify potential problems associated with the review of Pharmacy Establishment Plans (PEPs) and complex protocols.
  • Independently review and approve Pharmacy Establishment Plans. This includes interacting with outside stakeholders.
  • Participate in Division meetings and assist the Branch with coverage for the HIV/AIDS Clinical Trials Networks' full group meetings and provide summaries as needed.
  • Serve as a member of Branch and Office level working groups.
  • Participate in protocol team or clinical research site conference calls with direction from PAB pharmacist.
  • Work with PAB pharmacists in the development of protocol specific trainings for site pharmacists, which may include Power Point presentations and Manual of Operations.
  • Develop, review and revise processes and procedures for Branch operations (e.g. SOPs, work instructions, guidance documents, etc.), in coordination with PAB federal client.
  • Edit, rewrite, and/or proofread drafts of materials prepared by PAB pharmacists, as needed.
Specific Qualifications:
  • Bachelor's degree in a related field.
  • Minimum of 3 years experience as a Certified Pharmacy Technician.

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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