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.
- Assist with departmental documentation processes
- Other administrative or scientific duties as assigned
Preferably Bachelor's or Master's in Science
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.
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