Study Coordinator - Study Designer Specialist

Study Coordinator-Study Design Specialist
Greenfield, IN

Do you have 1+ years of Preclinical Animal Research Study experince along with expertise in software? Do you have basic coding skills and looking for a position that will take advantage of your strong Preclinical Aniaml Research knowledge and allow for your passion in software and reporting? The Study Coordinator-Study Design Specialist may be a match for you!

The Study Coordinator-Study Design Specialist will play a key role in transferring of data from current study management and other documentation systems into the new Study Designer Software system. In addition to testing and training on the new platform. This position will assist with coordinating the activities of routine and non-routine studies, in compliance with the appropriate company standards, GLP and regulatory guidelines in a timely, efficient manner. You'll also be responsible for providing general administrative assistance to Study Directors

• Transferring of data and setup of studies in new Study Designer Software system.
• Provides administrative and scientific support for toxicology studies, including pre study tasks (e.g., protocol development, costing, scheduling), monitoring the Inlife progress of assigned studies, and interacting with clients.
• Ensures study compliance with the protocol, standard operating procedures, Good Laboratory Practices, and other regulatory guidelines.
• 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.
• Reviews data and identify deficiencies.
• Compiles data for clients for regular study progress updates.
• 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.
• Assists the Study Director in monitoring the financial status of ongoing studies, including completion of work scope changes as applicable.
• Independently uses project tracking
• 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

• 1+ years of hands-on work performing preclinical animal research studies at Labcorp. 1+ years of work on GLP studies
• Preferred but not required 1 year of Labcorp Early Development Study Coordination experince
• AS Veterinary Technology or related field OR BS/BA in Animal Science, Animal Behavior, Biology, Wildlife Studies, Zoology or Related Life Sciences OR 2 years of college courses in Life Sciences field with 2 years of laboratory experience or 2 years of animal handling experience.
• AALAS certification at the Assistant Laboratory Animal Technician level is preferred but not required.
• 1+ years of experience using Pristima software, 1+years of experince with CMS (content management systems) such as Documentum.
• Highly prefer candidate with strong preclinical toxicology experince
• Prefered but not required coding experince,