Posted on: August 16, 2019
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
- 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
- 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.
- 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
- 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
- Excellent communication and interpersonal skills with great
attention to detail
Keywords: Covance, Madison , Pharmacokinetics Coordinator, Other , Madison, Wisconsin
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