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Covance Assist Study Coord, Metabolism in Greenfield, Indiana

Job Overview:

Covance by Labcorp is a leading contract research organization (CRO) that provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 26,000 people worldwide, we provide comprehensive drug development solutions and are on a mission to advance health and power clear, confident decisions.

Assist Study Coordinator, Metabolic Studies

The Assist Study Coordinator 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:

Relevant degree in life Science or related field plus 2 years of appropriate experience preferably in pre-clincal (animal) research studies. Experience may be substituted for academic qualifications.

Experience:

Strong software skills using wordprocessing, databases, spreadsheets, and specialised software related to reserach studies.

Skilled in the use of all standard laboratory equipment

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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