Covance

  • Assistant Study Coordinator- Metabolism

    Job Location(s) US-WI-Madison
    Job Number
    2018-23481
    Job Category
    Scientific Mid-Level
    Position Type
    Full-Time
  • Job Overview

    Assistant Study Coordinator- Metabolism

    • Learns to draft protocols, amendments and study schedules as appropriate using study outline or client supplied information
    • Learns to review study compliance against protocol, SOP and regulatory agency guidelines
    • Learns to prepare 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 learns to assist 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.
    • Communicates and interacts with study team (SD’s and operational staff)
    • Learns to serve as the primary contact in communication and interaction with other departments and clients as applicable
    • Learns to maintain well documented, organized and up-to-date study files including study schedule, protocol and correspondence.
    • Learns to assists SD/PI in monitoring in-life and analytical phases of studies, 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.
    • Learns to assist in interpreting and evaluating data for reports
    • Participates in the peer review process for scientific reports
    • Learns to review 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.
    • Reviews client comments with SD/PI and ensures that all necessary report/raw data clarifications are completed.
    • Learns to manage increasingly complex projects and study designs
    • Learns the process of report production through finalization, including archiving of data as appropriate.
    • Learns to participate in routine client visits under direction of the SD/PI. Interacts/communicates with client as necessary.
    • Maintains an awareness of the financial status of ongoing studies, including work scope changes
    • Performs other related duties as assigned.
    • Consistently and continuously responds efficiently to requests (delivers high quality output on time).
    • Builds positive relationships with both internal/external clients.
    • Uses experience and knowledge to contribute to design of new process or program in primary area of work.
    • Works with the team to identify obstacles to change.
    • Recognizes changing situations and priorities and adapts accordingly.
    • Follow instructions, SOPs and protocols that apply to current role to complete assigned tasks and projects.
    • Demonstrates ability and desire to learn and develop self.
    • Places organizational goals before personal interests and demonstrates the ability to engage in team building.
    • Supports and encourages others in their work.
    • Ability to schedule daily tasks to coincide with own study deadlines.
    • Ability to recognize deviations from normal results and inform Study Director and/or management of any problems that may affect integrity of the data.
    • Ability to understand the scope of a study (primary area of work) and be able to complete tasks with no or minimal supervision

    Education/Qualifications

    • Relevant degree plus 2 years of appropriate experience. Relevant experience may be substituted for academic qualifications.

     

    Experience

    • Ability to utilize word processing, databases, spreadsheets, and specialized software on personal computers.
    • Skilled in the use of all standard laboratory equipment.

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