Study Coordinator - Toxicology

Labcorp•Madison, WI

2d•Onsite

About The Position

The Study Coordinator is responsible for providing high-level organizational support for preclinical (animal research) study tasks, including managing timelines and preparing and delivering client communications in alignment with company standards, GLP, and regulatory guidelines. This role plays a key part in ensuring studies run smoothly, efficiently, and with exceptional scientific and operational quality.

Requirements

Bachelor’s degree in a related science field
Strong editing and formatting skills in Microsoft Word & Excel, such as imbedding graphs, columns, headers and footers, use of filters and pivot tables
Excellent written and verbal communication skills
1 or more years of experience simultaneously handling multiple priorities to meet project and client requirements

Nice To Haves

MS Degree preferred
1 or more years of preclinical research experince (animal studies)
1 or more years of experience managing deliverables to clients in business-to-business environment
1 or more years of experience in program and/or project management
Excellent organizational skills
Possess high degree of initiative
Ability to build strong internal and external client relationships
Consistently and continuously responds efficiently to requests (delivers high quality output on time)
Uses creative problem solving to challenging issues
Establishes clear plans and timelines to meet short- and medium-term requirements for projects
Anticipates issues/obstacles which may prevent meeting project/department objectives and identify solutions to overcome difficulties
Ability to recognize deviations from normal results and inform Study Director and/or management of any problems that may affect integrity of the data
Ability to recommend modifications to routine procedures to adapt to problems in primary area
Ability to understand the scope of a study (primary area of work) and be able to complete with no supervision.

Responsibilities

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.
Ensures compliance with the protocol, standard operating procedures, Good Laboratory Practices, and other regulatory guidelines.
Serves as a contact, along with the Study Director, in communication and interactions with other departments and clients, with assistance as applicable.
Compiles data for clients for regular study progress updates.
Draft protocols and amendments for Study Director Review and approval.
Ensure 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 pre-initiation meeting minutes.
Addresses 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.
Prepare shipping documentation including CITES application requests and any other associated shipping documentation, as required per study.
General assistance to Study Directors will be an essential part of the role and additional non-study specific support may be given to key clients.
Additional daily duties may include support of other functions within Safety Assessment.
Manages the workload of the associated responsibilities by planning and organization responsibilities, adjusting to address urgent needs as required.