CLINICAL OPERATIONS COORDINATOR

2 weeks ago


Bethesda MD USA, United States Veear Projects Inc Full time
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.



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