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Pharmacokinetics Coordinator

Company: Covance
Location: Madison
Posted on: August 16, 2019

Job Description:

Job Overview Covance is a drug development service company that, through unique perspective and precise delivery, has helped bring 49 of the top 50 best-selling drugs on the market today from potential into reality. Covance Pharmacokinetics department, a part of Clinical Pharmacology Services (CPS), focuses on the movement of a chemical (drug) into, through, and out of the body-the time course of its absorption, bioavailability, distribution, metabolism, and excretion. We are seeking a Pharmacokinetics Coordinator to join our team in our Madison, Wisconsin office. The Pharmacokinetics Coordinator will assist the Pharmacokineticist with certain tasks related to PK analysis, reporting, QC, and communication. You will have the opportunity to make an impact on the lives of patients, partner with and learn from supportive colleagues and industry leaders, and open up new opportunities for career growth. If you have a strong interest in PK and would like to grow within a PK organization, this is an excellent opportunity to break into this field. Duties and Responsibilities:

  • Liaise with the relevant bioanalytical departments over the transfer of clinical PK and PD data.
  • Create and maintain PK Analysis Plan (PKAP) under supervision.
  • Conduct non-compartmental (NCA) PK analysis in accordance with the protocol, protocol amendments and/or PKAP with guidance.
  • Prepare PK analysis methodology sections and compile stand-alone PK report tables and figures under guidance.
  • Conduct non-compartmental analysis on clinical datasets for use in interim PK reports under guidance.
  • Draft interim clinical PK reports, including Tables, Figures and Listings.
  • Perform QC checking of analysis datasets and/or reports (text, tables and figures) for CPS and stand-alone PK studies to ensure accuracy and completeness.
  • Review QA/QC report audits and Sponsor comments for CPS and stand-alone PK reports with the study Pharmacokineticist. Respond to and incorporate QA/QC findings and Sponsor comments into the final reports under guidance.
  • Proactively communicate and interact with study team, other departments, and clients.
  • Assist study Pharmacokineticist in communication and interaction with other departments and clients, as applicable.
  • Participate in process improvement projects to increase the efficiency of procedures and reporting methods.
  • Archive clinical PK data in a timely manner. Education/Qualifications
    • Bachelor's degree in Life Sciences or Mathematics; relevant experience may be substituted for education Experience
      • At least one year of general experience in relevant scientific or clinical fields (PK, BioA, Pharmacology) with a strong interest in PK
      • Ability to learn and utilize PK software (Phoenix WinNonlin), word processing software, database, spreadsheet, and other specialized softwares like SigmaPlot
      • Proven ability to plan, prioritize, and manage a workload in a fast-paced environment
      • Excellent communication and interpersonal skills with great attention to detail

Keywords: Covance, Madison , Pharmacokinetics Coordinator, Other , Madison, Wisconsin

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