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Covance Associate Study Coordinator in Greenfield, Indiana

Job Overview:

Covance Inc., the drug development business of LabCorp®, is the world’s most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real®. Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug development data in the world, along with our innovative technology solutions, help our clients identify new approaches and anticipate tomorrow’s challenges as they evolve.

Assist Study Coordinator, Pharmacokinetic Studies

The Assist Study Coordinator, Pharmacokinetic Studies will play a key role in coordinating client and internal team activities. This position serves as the primary contact for communication and interaction with other departments and clients. Duties include but not limited to:

  • Draft protocols, amendments and study schedules as appropriate using study outline or client supplied information

  • Prepares study schedules based on input from Study Director (SD)/Principal Investigator (PI)

  • Schedules and participates in client, pre-initiation and other study related meetings as required.

  • Will review study compliance against protocol, SOP and regulatory agency guidelines

  • Schedules and participates in client, pre-initiation and other study related meetings as required.

  • Reviews progress and study status against initial work plan – maintains CMS with accurate schedules.

  • Maintains a 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, if applicable.

  • Performs QC on data tables and figures, reviews process for protocols/amendment and 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.

  • Reviews client comments with SD/PI and ensures that all necessary report/raw data clarifications are completed.

  • Maintains an awareness of the financial status of ongoing studies, including work scope changes

Education/Qualifications:

  • Bachelor degree in Life Sciences, or similar in addition to 2 years of relative experience. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education.

  • Strong knowledge of Microsoft Word, Excel, PowerPoint and SharePoint

  • Excellent communication skills

  • Excellent time management skills along with ability to prioritize complex task with competing timelines

Experience:

  • Sufficient knowledge and understanding in pre-clinical (animal research studies) to analyze progress compared to protocol and interpret data findings

  • Knowledge of basic laboratory equipment such as centrifuges, pipettes, stir plates, etc

  • Prior experience reviewing data for accuracy and assembling complex reports and presentations

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

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