Study Coordinator I

Altasciences•Columbia, MO

About The Position

The Study Coordinator I supports and coordinates the planning, execution, and reporting of nonclinical studies under the guidance of Study Director(s). The role is responsible for study administration, scheduling, documentation, compliance monitoring, and cross-functional coordination to help ensure studies follow protocols, standard operating procedures (SOPs), and regulatory guidelines. The coordinator provides support for assigned studies from initiation through finalization, with increasing responsibility over time. Depending on site structure and study needs, duties may include coordinating short-term acute non-GLP studies and GLP studies, supporting in-life activities, preparing study documentation and reports, monitoring compliance, coordinating client interactions, and assisting with sample shipping and inventory.

Requirements

Bachelor’s degree or college coursework in a scientific discipline, with 0–1 years of experience in a scientific environment, or an equivalent combination of education and experience.
Proficiency with the MS Office Suite.
Ability to read and interpret technical documents and industry-specific manuals.
Ability to write advanced documents and correspondence.
Ability to speak effectively before groups of customers or employees.
Ability to multitask and stay organized in a fast-paced, changing environment.
Strong planning and organizational skills.
Ability to work effectively and cooperatively in a team under significant time pressure.
Demonstrated attention to detail and consistent ability to work accurately and with quality.
Applicants must be legally authorized to work in the United States and must not require employer sponsorship now or in the future.

Nice To Haves

Bilingual proficiency in French may be required, depending on location.

Responsibilities

Assist with preparing, reviewing, and distributing study protocols and amendments; with experience, independently draft study documentation.
Coordinate and/or participate in protocol review, pre-initiation, and study-related meetings.
Review study schedules for data collection in the electronic data capture system and review schedule changes resulting from amendments as needed.
Assist with creating, reviewing, and maintaining study planning documents, such as Project Review Forms or study outlines.
Assist with preparing and maintaining study notebooks, study forms, and other study materials.
Support and coordinate day-to-day study activities across functional departments to ensure alignment with study plans.
Track study progress, milestones, and deliverables, and communicate status updates to Study Director(s) and stakeholders.
As needed, review study data, records, and processes for accuracy, completeness, and compliance; identify discrepancies, coordinate data issue resolution, and escalate deviations to Study Director(s).
Generate data tables for reports and perform data verification as needed.
Coordinate assigned studies from initiation through finalization and support or assist with monitoring in-life study activities as appropriate.
Support compliance monitoring throughout the study lifecycle.
Assist with preparing, compiling, and formatting study reports, including drafting sections such as Materials and Methods and participating in peer review, as applicable.
Collect and collate final report components under the Study Director’s guidance using electronic publishing tools.
Maintain accurate, organized, audit-ready study documentation, including study files, schedules, and correspondence; support archiving and study finalization as needed.
Assist with quality assurance activities, including audit preparation and response coordination.
Support Study Director(s) in coordinating and preparing for client interactions and visits.
Serve as a key point of contact for internal communication across departments for assigned study activities, as needed.
Provide coordination for short-term, acute, non-GLP studies from initiation to finalization under Study Director guidance; may also coordinate GLP studies.
Provide backup support to Study Director(s), including communicating study status to stakeholders.
May prepare and verify sample manifests and coordinate sample shipping and inventory.