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Associate Study Coordinator- Metabolism

Covance 1/1/2019 4:23:54 PM
JOB ID: 23481 Category: Scientific Mid Level
Madison, Wisconsin

   

 

Job Overview

Do you have a passion for Science? Writing? Accuracy? Please keep reading…

We have a great opportunity for an Associate Study Coordinator in our Drug Metabolism Department at our Madison, WI lab. Covance's work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.

In this role, you will be responsible for coordinating the activities of routine and non-routine studies 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.

Duties and Responsibilities:

* Drafts protocols, amendments, and study schedules as appropriate using study outline or client supplied information
* 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
* Proactively communicates and interacts with study team (SD's and operational staff) 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 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.
* Assists in interpreting and evaluating data for reports
* Participates in the peer review process for scientific reports
* Reviews QAU report audit sand client comments with SD/PI or appropriate laboratory group. Submits audit responses for SD/PI approval. Ensures that all necessary report/raw data clarifications are completed.
* 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. Learns to host routine client visits and interacts/communicates with client as necessary.
* Maintains an awareness of the financial status of ongoing studies, including work scope changes
* Begins to act as a basic project coordinator for assigned clients(s) across the metabolism discipline

Education/Qualifications

* Relevant degree (i.e. Life Sciences) plus 3 years of appropriate Experience ; relevant Experience may be substituted for academic qualifications
* At least 1 year at previous level (internal applicants only)

Experience

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


Position Type: Full-Time

Location: Madison, WI - Wisconsin



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Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).