Study Coordinator IV – Safety Assessment / Harrogate, North Yorkshire, UK
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 IV 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. Is familiar with standard operating procedures, capabilities, and regulatory guidelines. Serves as a team resource for questions related to these topics. Provides leadership to study teams and successfully manages difficult projects. May lead client or internal discussions, with input from Study Director, related to study design changes and study issues. 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. Maintains proficiency and trains less experienced Study Coordinators to use specific software used in study conduct, project tracking and reporting. Maintains familiarity with routine study procedures and becomes familiar with specialized study procedures. Monitors progress and status of assigned studies. Reviews data and identifies and resolves 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 or independently hosts client visits. May assist with regulatory visits as appropriate. Performs QC (peer) reviews on study reports. Monitors the financial status of ongoing studies, including completion of work scope changes, as applicable. Undertakes other administrative or scientific duties as assigned. Assist SD by ensuring that study documentation such as Literature Reviews and Animal Order Forms are in place Preparation and checking of CTD tables as required Prepare shipping documentation including CITES application requests and any other associated shipping documentation, as required per study 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. Manages increasingly complex projects and study designs while taking on an increased workload. Provides 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. Conducts independent proposal management activity upon request and under supervision of Management and/or Study Directors. Begins to focus career development goals towards an area of specialization in toxicology. General duties: Attend SD communication meetings as applicable and prepare minutes Assist with the development of team policies, procedures and training manuals Train and mentor other Study Coordinators Provide assistance (as required) for other Study Coordinators 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 Five to seven years of experience of safety assessment or relevant field or three to five years of experience in safety assessment (or relevant field) with a Master’s Degree in a related science field.