Responsibilities:

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.

Learns to ensure study compliance with the protocol, standard operating procedures, Good Laboratory Practices, and other regulatory guidelines.

Learns to coordinate the study award process as applicable

Learns to coordinate the efforts of a study team to become a successful project manager.

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 maintain complete, organized, and current study files including study schedule, protocol, and applicable correspondence.

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.

Initiates and submits costing and scheduling requests with assistance.

Schedules and participates in preinitiation 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.

Verifies the project schedule accurately reflects the requirements of the protocol.

Learns to monitor progress and status of assigned studies with assistance.

Learns to review data and identify deficiencies.

Learns to compile data for clients for regular study progress updates.

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.

Learns to perform QC (peer) reviews on study reports.

Undertakes other administrative or scientific duties as assigned.

Learns to use project tracking systems, as appropriate

Learns to assist the Study Director in monitoring the financial status of ongoing studies, including completion of work scope changes as applicable.

Assist SD by ensuring that study documentation such as Literature Reviews and Animal Order Forms are in place

May assist with the preparation (with guidance) CTD tables

Prepare shipping documentation including CITES application requests and any other associated shipping documentation, as required per study

Requirements:

Bachelor's or Master's degree

Proficient in English reading and writing

Major in a field related to biomedicine or pharmaceuticals

1–3 years of experience in project coordination

Stable and reliable work attitude; responsible and detail-oriented