COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
We are recruiting for our Early Compound Development Unit team in Harrogate and are currently seeking to hire an Assistant Study Coordinator to help support the metabolism-Study Direction team to conduct all work in compliance with appropriate company standards, GLP, GCP, GMP (where appropriate) and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved.
This is a full time permanent position, based in our site in Harrogate.
About the Job
Within this position, your duties will include:
• Performs general administrative tasks to support the department
• Develops understanding of study outlines, study protocols/amendments, study schedules, regulatory requirements, and Covance SOPs/P&Ps as they pertain to client deliverables (i.e. shipping, archival, data retrieval, and compilation etc.)
• Develops understanding of client-specific requirements for cover letters, inventories, or additional materials, as appropriate
• Performs format Quality Control (QC) on protocols and amendments prior to distribution
• Performs internal and external distribution of definitive protocols and amendments as a PDF document and distributes to sponsor, Study Director (SD) & Quality Assurance (QA) as appropriate
• Compiles and maintains appropriate storage of wet signature pages
• Maintain departmental data store for cleanliness & data organisation
• Maintains well documented, organized and up-to-date study files/data skips including correspondence
• Schedule and participate in study related meetings, take and distribute meeting minutes
• Prepares study schedule requests/changes based on input from SD/Principal Investigator (PI), places information into databases and communicates work plan to laboratory personnel and support groups, as applicable
• Reviews progress and study status against initial work plan – maintains CMS with accurate schedules
• Ensure department master schedule is up to date
• Maintain departmental eTracking system
• Collates study data from all necessary departments & ensures each package of data is assigned a tracking ID & tracked accordingly
• Proof checks data tables and figures prepared by others
• Performs format QC on draft, final and PDF reports prior to distribution ensuring that the most recent template has been used on each occasion
• Performs internal and external distribution of draft & final reports and distributes to sponsor, SD & QA as appropriate
• Tracks on time reporting as a departmental metric & provides analysis of the data
• Participates in improvement projects to increase the efficiency of routine procedures and reporting methods
• Prepares required paperwork for document and/or supply shipments in a timely, efficient, and error-free manner
• Completes paper and electronic study archiving within 2 days of finalisation
• Appropriately file and store archive summary forms and ensure personnel such as the SD & Application Administrator (AA)'s are notified of acceptance into CSR
• Maintains departmental records and notifies necessary personnel of study finalisation/archival
• Performs other related duties as assigned.
The opportunity to work within an experienced and highly skilled team.
Covance offers a comprehensive benefits package including health cover and contributory pension.
Covance’s ongoing success offers team members unsurpassed growth and career development opportunities.
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.
There is no better time to join us!
• Relevant degree plus 0-1 years of appropriate experience or 4 years of related practical experience.
• Ability to utilise word processing, databases, spreadsheets, and specialised software on personal computers.
• Skilled in the use of all standard laboratory equipment