Vitalograph is a world leading manufacturer of quality cardio-respiratory diagnostic devices with over 50 years' experience in supporting their use in respiratory medicine and clinical. We now wish to recruit additional personnel to be part of our future growth.
Reporting to: Quality Assurance Officer
Roles with potential to provide cover: Quality Assurance Officer
The role has the following key responsibilities within Vitalograph; this information should be used to identify Competency requirements, with additional reference to relevant ‘Training requirement Plans':
1. Assisting the Quality Assurance Officer with Documentation Control to include, issuing new documentation, managing change control and maintenance of tracking spreadsheets.
2. Assist the Quality Assurance Officer with study file reviews as per the audit schedule.
3. Carry out training reviews for all staff involved in Clinical Trials.
4. Administration of Clinical Trial competency training materials.
5. Assist the Clinical Trials Archivist with management of the Central Filing room.
6. To assist project and data management teams in the preparation, updating, printing and distribution of study specific documentation as appropriate:
a. Study-specific procedures
b. Status reports
c. Study manuals
d. Study newsletters and merge letters, etc.
e. Scanning/filing documents
7. Assisting with problem solving issues
8. Other reasonable tasks as requested by the Quality Assurance Officer, or Vitalograph Management.
Outline of skills required:
The following competencies are required for any Personnel undertaking this role; this information should be compared to 'CVs' and 'Employee Training and Development Records to identify knowledge gaps/future training needs.
1. Document control / training system management or equivalent
2. Demonstrated organizational skills
3. Good communication skills - verbal and written
4. Attention to detail
8. Working knowledge of ICH GCP and appropriate regulations
9. Can handle boring or repetitive tasks
10. Supportive and reliable
11. Problem solving skills
13. Proficient use of word, excel
14. Decision making
18. Good grasp of written English language and grammar
Training will be given where necessary.
Please apply with CV to: firstname.lastname@example.org