Covance

  • Associate Study Coordinator- PK/TK

    Job Location(s) US-WI-Madison
    Job Number
    2018-25026
    Job Category
    Scientific Mid-Level
    Position Type
    Full-Time
  • Job Overview

    Individual has responsibility for coordinating the activities of routine and non-routine studies for one business line (Noncompartmental analysis) in compliance with appropriate company standards, GLP, GCP, GMP and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved in a timely, efficient and quality manner.

     

    • Performs initial review of analytical data and originates noncompartmental analysis in support of pharmacokinetic and toxicokinetic studies
    • Reviews study compliance against protocol, SOP and regulatory agency guidelines
    • Prepares study schedules based on input from Study Director (SD)/Principal Investigator (PI), places information into databases and communicates work plan to laboratory personnel and support groups, as applicable.
    • Participates in and assists SD/PI with pre-initiation and other study related meetings as required
    • Reviews progress and study status against initial work plan – maintains CMS with accurate schedules.
    • Proactively communicates and interacts with study team to ensure key milestones are achieved
    • Serves as the primary contact in communication and interaction with other departments and clients as applicable
    • Maintains well documented, organized and up-to-date study files including study schedule, protocol and correspondence.
    • Assists SD/PI in the PK/TK study phase, if applicable and review of study compliance with protocol, SOPs and regulatory guidelines.
    • Aids in report preparation, including tables and figures. Compiles analytical information from laboratory groups.
    • Assists in the development and maintenance of standard report/table formats as required
    • Assists in interpreting and evaluating data for reports
    • Participates in the peer review process for scientific reports
    • Reviews QAU report audits with SD/PI or appropriate laboratory group. Submits audit responses for SD/PI approval. Ensures that all necessary report/raw data clarifications are completed.
    • Learns to deputize for SD in their absence with ability to provide updates to internal/external customers
    • Reviews client comments and makes decisions in conjunction with SD/PI and ensures that all necessary report/raw data clarifications are completed.
    • Regularly manages increasingly more complex projects and study designs and/or increased study load
    • Responsible for and drives report production through finalization, including archiving of data as appropriate.
    • Prepares for and participates in routine client visits under direction of the SD/PI. Hosts routine client visits and interacts/communicates with client as necessary.
    • Maintains an awareness of the financial status of ongoing studies, including work scope changes
    • Develops an area of expertise within the department and serves as a resource by providing training and written instructions
    • Develops knowledge of Covance metabolism capabilities such that they can coordinate (with supervision) one other area outside of their area of expertise
    • Learns to expand responsibilities as a project coordinator for assigned clients(s) across the metabolism discipline
    • Performs other related duties as assigned.

    Education/Qualifications

    • Relevant degree plus 4 years of appropriate experience. Relevant experience may be substituted for academic qualifications.
    • At least 18 months at previous level

    Experience

     

    • Ability to utilize word processing, databases, spreadsheets, and specialized software on personal computers.
    • Skilled in the use of all standard laboratory equipment
    • Excellent communication, presentation, and interpersonal skills.
    • Excellent attention to detail.
    • Ability to prioritize and manage time.

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