Covance jobs - Study Coordinator I

Job Overview

Provide the necessary support to the department with respect to documentation and plan adherence such that Study Directors, Contributing Scientists, Principal Investigators, and/or Study Managers (SD/CS/PI/SM) and scientific staff are able to fulfil all regulatory and service delivery expectations.

General Job Responsibilities 

• Provide practical and logistical support to (SD/CS/PI/SM) and scientific staff such that they are able to fulfil all regulatory and service delivery expectations
• Assist in the preparation of study documentation
• Assist in the preparation and revision of Standard Operating Procedures
• Assist with the generation of tables, graphs, and data sets using specific software and systems.
• Assist with the timely archiving of study documentation and/or related study materials
• Report any difficulty, uncertainty or unexpected finding to SD/CS/PI/SM as appropriate.
• Perform any function within the competence and experience of a Study Coordinator that may be required by the Company
• Assist with updating various indexes and logs
• Assist with keeping distribution lists, etc. updated with staff changes
• Assist with preparation of Training files
• Run quarterly stock take
• Develop understanding of project tracking systems
• Regulatory & Quality
• Addresses and reviews quality assurance audits or client inspections as required.
• Develop a thorough working knowledge of national and international GLP/GCP regulations and their application to the work area
• Accept responsibility for own GLP/GCP compliance
• Understanding of I&I assays
• Develop a working knowledge, including regulations, of analytical method validation and sample analysis.
• Misc. items
• Assist with departmental documentation processes 
  

Other administrative or scientific duties as assigned

Education/Qualifications

Preferably BS/BA/BSc (Hons) or equivalent.

Equivalent years of experience may be substituted for education.

Experience

The post holder should typically have:

• Computing skills, including word processing and use of spreadsheets (e.g. Word, Excel).
• The post holder should be able to communicate effectively at all levels with other Covance employees, as well as external clients, suppliers etc.
• Strong organizational skills
• Strong English writing and communication skills.