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Study Coordinator
III - Nutritional Chemistry & Food Safety - Madison, WI
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Requisition ID
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18811BR
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Job Category
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Other
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Locations
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USA -
Madison, WI
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Shift
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1
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Job Posting
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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.
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Education/Qualifications
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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.
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Experience
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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.
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Start time
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7:30
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End time
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4:15
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Days per week
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5
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Apply
Here
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