Covance’s work in developing new pharmaceutical solutions has a positive impact on the lives of millions worldwide and there are several great opportunities for you to be a part of this life-saving work.
At our pre-clinical development site in Harrogate, North Yorkshire, we currently have an exciting opportunity to join our team as an Associate Study Coordinator in the Department of Genetic Toxicology.
About the job:
Associate Study Coordinator provides administrative and scientific support for Genetic Toxicology studies including pre‑study tasks (i.e., protocol development, costing, scheduling),monitoring the in-life progress of assigned studies, interacting with clients and preparing report components (i.e. drafting progress reports, writing report procedures, and reviewing results and conclusions in final reports for accuracy)
- Provides backup support for Study Director on day to day study specific activities or tasks.
- Coordinates packages of work.
- Participates in pre study meetings, and other study-related meetings, as required.
- Drafts protocols and amendments for Study Directors’ review and approval with minimal supervision.
- Verifies that study schedule accurately reflect the requirements of the protocol.
- Coordinates study and reporting process on assigned studies.
- Monitors experimentation on routine and specialised studies and reports any problems or deviations to the Study Director.
- Manages acquisition of test article and relevant documentation and ensures internal distribution.
- Ensures that all client report comments are addressed and documented in a timely manner and monitors the final report issue, contacting clients where necessary to request comments in order to meet regulatory/Covance timelines.
- Manages electronic study correspondence to ensure availability in a central folder and that appropriate messages are transferred to archives at finalization.(US specific process)
- Initiates scheduling requests and schedule changes redirects any costing, quote, and work scope changes to more senior level personnel.
- Learns organisation of multi-site studies.
- Reviews data output from the lab areas and identify deficiencies.
- Writes and prepares study procedures, tables and graphs for the report.
- Conducts QC checks of reports for accuracy and completeness, reflecting the protocol, Covance SOP’s, and raw data, as appropriate
- Conducts formal peer reviews
- Learns to coordinate the receipt and incorporation of internal and external contributor reports.
- Addresses QA audits relating to reports.
- Acts as alternative contact for the Sponsor in the absence of the Study Director.
- Learns additional Client Management responsibilities as appropriate. These may include but are not limited to: status updates, invoicing queries, scheduling, work scope changes, specific client requirements.
- Assists with or co-hosts client visits and writes up debriefing notes.
- Maintains awareness of specific software used in study conduct.
- Maintains familiarity with routine study procedures and contributes to changes.
- Identifies opportunities for process improvement and assists in their resolution
Specific Responsibilities with regards to regulatory compliance
- The individual has a responsibility to conduct all work (where appropriate) in compliance with applicable regulatory requirements, and specifically those regulations (GLP; GCP OR ISO17025) specified in the study plans, protocols, or work agreements governing the work in which they are involved