Job Tittle: Study Coordinator III – Safety Assessment
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 a Study Coordinator III in Safety Assessment Department.
The job summary is as follows:
- Provides administrative and scientific support for toxicology studies, including prestudy tasks (e.g., protocol development, costing, scheduling), monitoring the inlife progress of assigned studies, and interacting with clients.
- Provides administrative backup support for Study Directors on day to day study-specific activities or tasks.
- Ensures study compliance with the protocol, standard operating procedures, Good Laboratory Practices, and other regulatory guidelines.
- Coordinates the study award process as applicable
- Coordinates the efforts of a study team to become a successful project manager.
- Plans, prioritize, and manage a workload and the associated responsibilities.
- Serves as a contact, along with the Study Director, in communication and interactions with other departments and clients, with assistance as applicable.
- Maintains complete, organized, and current study files including study schedule, protocol, and applicable correspondence.
- Drafts protocols and amendments for Study Director Review and approval.
- Ensures all client comments on protocols and amendments are addressed in a timely manner.
- Initiates and submits costing and scheduling request.
- Schedules and participates in preinitiation and other study-related meetings, as required, and takes and distributes preinitiation meeting minutes.
- Drafts and submits appropriate documents to the IACUC/AWERB for approval
- Verifies the project schedule accurately reflects the requirements of the protocol.
- Monitors progress and status of assigned studies.
- Maintains proficiency in specific software used in study conduct, Project tracking and reporting and uses independently as appropriate.
- Maintains familiarity with routine study procedures.
- Reviews data and identifies deficiencies.
- Addresses and reviews quality assurance audits relating to protocols and amendments and reports (as applicable), with oversight. Follows up with appropriate personnel to ensure all necessary document/data clarifications are completed in the specified timelines.
- Co-hosts client visits.
- Performs QC (peer) reviews on study reports.
- Communicate timelines to Principal Investigators (PI) and support groups as applicable.
- Identifies opportunities for process improvements and assists in their resolution. May participate in other process improvement teams.
- Begins to manage increasingly complex projects and study designs while taking on an increased workload.
- Begins to provide input and assist with implantation of new technology and system changes/upgrades/enhancements.
- Learns to implement action plans for solving study problems as they occur, including participation in client issue resolution process and any associated internal or external discussion.