Study Coordinator III - Nutritional Chemistry & Food Safety - Madison, WI

 

Requisition ID

18811BR

Job Category

Other

Locations

USA - Madison, WI

Shift

1

Job Posting

Performs activities related to the Project Management process by coordinating activities for routine and non-routine studies in compliance with appropriate protocol, Standard Operating Procedure (SOP) and regulatory agency guidelines, in a timely, efficient, and quality manner.

ESSENTIAL JOB DUTIES:
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.
Develops new report formats as needed, including client specific formatting.
Identifies and leads process improvement to increase the efficiency of daily/routine procedures, reporting methods, and departmental practices.
Serves as the primary contact in communication and interaction with other departments and clients as applicable.
Updates and maintains project tracking systems as appropriate. Provides input on new technologies, system changes, and enhancements.
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. Compiles analytical information from laboratory groups.
Assists in interpreting and 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. Submits audit responses for approval as appropriate. Follows up with appropriate personnel to ensure that all necessary report/raw data clarifications are completed within specified timelines.
Reviews client comments and makes decisions, including appropriate study personnel as necessary, to ensure that all necessary report/raw data clarifications are completed.
Drives report productions through finalization, including archival of data as appropriate.
Prepares for and hosts routine client visits.
Manages data transfer to clients as requested.
Monitors and schedules study phases in coordination with SD/PI.
Trains and mentors less experienced staff.
Assists SD/PI in monitoring the financial status of ongoing studies, as appropriate.
Assists in development of departmental policies, procedures, and training manuals.
Develops an area of expertise within the department, serves as a resource by providing training and written instructions.

OTHER JOB DUTIES:
Performs other related duties as assigned.

SPECIAL FACTORS:
Overtime and weekend work as required.
Mandatory immunizations and screening as required.
May work with potentially hazardous substances and/or radiolabeled materials.


GUIDELINE FOR PROMOTION:
Demonstrates consistent and sustained capability/willingness to perform at the next Study Coordinator level.
Demonstrates extensive experience in effective verbal and written communication.
Works on routine tasks independently, with minimal or no supervision.
An organizational need.

Education/Qualifications

MINIMUM EDUCATION/EXPERIENCE/SKILLS/REQUIRED LICENSES OR CERTIFICATIONS:
Bachelor degree in science plus four years of Study Coordinator experience. Relevant experience may be substituted for education.
Excellent communication, presentation, and interpersonal skills.
Excellent attention to detail.
Proficient in concise writing. Writing should require little or no external review or edit.
Proficient use of word processing software, database, spreadsheet, and specialized software.
Adherence to proper grammar, punctuation, composition, and spelling according to company standard conventions.
Efficient in prioritizing and managing time.
Experience on and understanding of a variety of studies performed in the department and exposure to a diverse client base.
Knowledge and understanding of regulatory agency guidelines.

Experience

MINIMUM EDUCATION/EXPERIENCE/SKILLS/REQUIRED LICENSES OR CERTIFICATIONS:
Bachelor degree in science plus four years of Study Coordinator experience. Relevant experience may be substituted for education.
Excellent communication, presentation, and interpersonal skills.
Excellent attention to detail.
Proficient in concise writing. Writing should require little or no external review or edit.
Proficient use of word processing software, database, spreadsheet, and specialized software.
Adherence to proper grammar, punctuation, composition, and spelling according to company standard conventions.
Efficient in prioritizing and managing time.
Experience on and understanding of a variety of studies performed in the department and exposure to a diverse client base.
Knowledge and understanding of regulatory agency guidelines.

Start time

7:30

End time

4:15

Days per week

5

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