Covance Study Coord III in Indianapolis, Indiana

Job Overview

Covance is currently seeking a Study Coordinator III in the BioA group in Indianapolis, IN.

Responsibilities Include:

  • Independently drafts protocols, sample analysis outlines (SAOs), amendments and study schedules as appropriate, using proposal outline or client-supplied information.

  • Reviews study compliance against protocol, SOP, and regulatory agency guidelines.

  • Assists in the development of new report formats as needed.

  • Improves processes to increase the efficiency of daily/routine procedures and reporting methods.

  • Serves as the primary contact in communication and interaction with other departments and clients as applicable.

  • Updates and maintains project tracking systems as appropriate.

  • Participates in and assists Study Director/Principal Investigator (SD/PI) with pre-initiation and other study related meetings, including scheduling and leading meetings as required.

  • Responsible for report preparation, including table and figure preparation.

  • Assists in evaluating data for reports.

  • Maintains well documented, organized, and up-to-date study files including study schedule, protocol, and correspondence, as applicable.

  • Reviews QAU report audits and submits audit responses for approval as appropriate.

  • Reviews client comments and makes decisions, including appropriate study personnel as necessary, to ensure that all necessary report/raw data clarifications are completed.

  • Responsible for report production through finalization, including archival of data as appropriate.

  • Prepares for and participates in routine client visits.

  • Manages data transfer to clients as requested.

  • Assists SD/PI in monitoring study phases.

  • Assists with training and mentoring less experienced staff.

  • Performs other related duties as assigned.

Education/Qualifications

  1. Bachelor of Science (BS) degree in science.

  2. Experience may be substituted for education.

  3. Efficient use of word processing software, database, spreadsheet, and specialized software.

  4. Proficient in concise writing; writing should require little or no external review or edit.

  5. Adherence to grammar, punctuation, composition, and spelling according to company standard conventions.

Experience

  1. Experience on a variety of studies performed in the department and exposure to a diverse client base.

  2. Knowledge of regulatory agency guidelines.

Job Number 2018-21674

Job Category Scientific Bachelor's Degree

Position Type Full-Time

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