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 handles 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 studies from initiation through finalization, with responsibility increasing over time and depending on site structure. Work may involve short-term, acute, non-GLP studies and may also include GLP studies. The position works with Study Director(s), internal functional departments, study support groups, sponsors, and other stakeholders. Duties may include reviewing study data and records, preparing report materials, supporting quality assurance activities, coordinating client interactions, and handling sample documentation and logistics. Some responsibilities vary according to site structure and may be performed under guidance.

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 environment under significant time pressure.
Demonstrated attention to detail and consistent ability to work accurately and with quality.
Must be legally authorized to work in the United States without 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 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 or amended protocols as needed.
Assist in creating, reviewing, and maintaining study planning documents, such as Project Review Forms or study outlines, under guidance.
Assist with preparing and maintaining study notebooks, study forms, and other materials needed for studies.
Coordinate day-to-day study activities across functional departments to align work with study plans.
Track study progress, milestones, and deliverables, and communicate status updates to Study Director(s) and stakeholders.
As applicable, review study data, records, and processes for accuracy, completeness, and compliance; identify discrepancies, coordinate resolution of data issues, 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 in monitoring in-life study activities and ongoing compliance.
Assist with preparing, compiling, formatting, and peer reviewing study reports, including drafting sections such as Materials and Methods, as applicable.
Collect and collate report components for final reports under Study Director guidance using electronic publishing tools.
Maintain accurate, organized, audit-ready study files, schedules, correspondence, and other documentation.
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; may serve as a key internal communication contact for assigned study activities.
Coordinate short-term, acute, non-GLP studies from initiation to finalization under Study Director guidance and may coordinate GLP studies.
Provide backup support to Study Director(s), including communicating study status to stakeholders.
As applicable, prepare and verify sample manifests and coordinate sample shipping and inventory.