Study Coordinator -DART

Labcorp•Greenfield, IN

15h•Onsite

About The Position

Labcorp is seeking an Study Coordinator to join our DART team in Madison, WI. Labcorp is a global leader in diagnostic testing and drug development solutions, helping healthcare providers, researchers, and patients make informed decisions that advance care. Join us in our mission to improve health and improve lives.

Requirements

Bachelor’s degree in animal science, biology, microbiology, toxicology, biomedical science, biochemistry, chemistry, pharmacology
Strong knowledge of office software (e.g., Microsoft® Office)
Excellent written and verbal communication skills
Comfortable working with data and reporting obtained from animal research studies
Excellent organizational skills
Ability to be able to work independently

Nice To Haves

3 months or more of pre-clinical research experience (animal studies)
3 months or more of experience with Veeva Systems software
3 months or more of experience in study coordination or administrative work

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.
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, prioritizes, and manages 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 requests with assistance.
Schedules and participates in pre-initiation and other study-related meetings, as required, and takes and distributes pre-initiation 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 with assistance.
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.
Assists with hosting client visits.
Performs QC (peer) reviews on study reports.
Undertakes other administrative or scientific duties as assigned.
Uses project tracking systems, as appropriate.
Assists the Study Director in monitoring the financial status of ongoing studies, including completion of work scope changes as applicable.
Ensures that study documentation such as Literature Reviews and Animal Order Forms are in place.
May assist with the preparation (with guidance) CTD tables.
Prepares shipping documentation including CITES application requests and any other associated shipping documentation, as required per study.