Study Coordinator III – Safety Assessment/ Harrogate, North Yorkshire, UK

Recruiter
Covance
Location
North Yorkshire
Posted
20 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
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. Education / Qualifications Bachelor’s degree in a related science field. Experience may be substituted for education. Additionally for UK: A minimum of English, Maths, and Science GCSEs, but preferably A level or above. Experience 4 to 5 years of safety assessment or relevant experience or 2 to 3 years of relevant experience with a Master’s Degree in a related science.

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