Study Coordinator - Toxicology

Description

• Provides administrative and scientific support for toxicology studies, including pre-study tasks (e.g., protocol development, costing, scheduling), monitoring the in-life progress of assigned studies, and interacting with clients
• Provides administrative backup support for Study Directors on day to day study-specific activities or tasks
• Learns to ensure study compliance with the protocol, standard operating procedures, Good Laboratory Practices, and other regulatory guidelines
• Learns to plan, 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
• Learns to draft protocols and amendments for Study Director Review and approval
• Ensures all client comments on protocols and amendments are addressed in a timely manner
• Schedules and participates in pre-initiation and other study-related meetings, as required, and takes and distributes preinitiation meeting minutes
• Learns to draft and submit appropriate documents to the IACUC/AWERB for approval
• Learns to address and review 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
• Assists with hosting client visits
• Assists Study Director by ensuring that study documentation such as Literature Reviews and Animal Order Forms are in place
• Prepares shipping documentation including CITES application requests and any other associated shipping documentation, as required per study

Qualifications

• BSc, preferably Life Science degree. Experience may be substituted for education

Skills / Experience

• Some experience or knowledge in Toxicology/Study Coordination or a client facing position
• Ability to demonstrate excellent communication and time management skills
• Excellent attention to detail and consistent accuracy whilst managing multiple changing priorities
• Knowledge of GLPs, regulatory agency guidelines and Home Office requirements