Job Information
Bureau Vertias North America Study Coordinator in Indiana
Overview:
Business Title: Study Coordinator
Position Title: Business Support II
Division: Consumer Products Services
Entity: ATL
Location: Indianapolis, IN
Reports to: Manager
FLSA: Non-exempt
Hours Worked:Typically, Monday through Friday, forty-hours per week.
However, must be flexible to meet the needs of the department and complete other projects as assigned.
Position Summary:
The Study Coordinator is responsible for driving the delivery, quality, and integrity of clinical trial data by coordinating study activities, managing documentation, overseeing sample workflows, and facilitating communication across multiple operational teams. This role ensures that clinical specimens, documentation, and data deliverables are processed, quality-checked, and delivered according to internal standards, regulatory requirements, and client expectations.
Duties and Responsibilities:
It is everyone’s responsibility to live out our Values and Absolutes by Shaping a World of Trust while ensuring responsible progress.
Coordinates all study-related activities including, but not limited to, study setup, administration, timelines, and day-to-day operational support
Tracks, manages, and monitors study progress, identifying bottlenecks and escalating risks as needed
Communicates data delivery timelines to analytical team and monitors progress
Assist with preparation of analytical and data reporting documentation
Performs data QC reviews to ensure accuracy, completeness, and compliance with analytical, regulatory, and client-specific requirements
Supports report writing and preparation of key study documents
Maintains, updates, and organizes study documentation in alignment with regulatory and internal quality standards
Coordinates sample receipt, tracking, and data capture through the LIMS system
Creates and/or verifies analyst plate maps within LIMS
Maintains sample status trackers and partners with analytical teams to ensure timely processing
Acts as a Jira administrator for study and department level workflows.
Supports document dashboards
Uses various digital tools and platforms to improve and support workflow efficiency, transparency, and traceability across study processes
Supports onboarding of new staff by helping with training materials, system introductions, and process walkthroughs
Provides guidance to team members on study workflows, technology tools, and documentation requirements
Participates in process improvements and assists in implementation of new tools and procedures
Participates in departmental meetings, study planning, and continuous improvement initiatives
Follow the guidelines set forth with clients and in the company Quality, Health, Safety and Environmental policies and procedures
Comply with clients and company management systems in accordance with appropriate regulatory agencies
Follow the guidelines set forth by clients in the company Quality Manual and Safety/Chemical Hygiene Plan
Other duties as defined by Manager, department needs and workload.
Skills & Proficiencies:
Strong ability to plan, prioritize, and manage multiple ongoing studies/tasks across cross-functional teams.
Strong organizational skills with the ability to quickly assess the status of multiple projects and adapt to changing priorities and requirements
Strong interpersonal and communication skills with the ability to collaborate effectively across departments.
Exceptional attention to detail and commitment to data integrity
Strong writing skills for reports, documentation, and structured communications.
High proficiency with digital tools (e.g., LIMS, Jira, Signals, dashboards/trackers, etc.) and ability to quickly learn new systems
Education and Experience:
Degree requirement: Bachelor's Degree in Biology, Project Management or closely related field
Minimum of one (1) year of experience with project management
Experience working in regulated environment preferred
Experience working in laboratory setting preferred
An equivalent combination of education and experience may be accepted in lieu of above.
Compensation Range: $27.00-$30.00 per hour (e.g., the job posting is not necessarily reflective of actual compensation that may be earned, and actual compensation is subject to variation due to such factors as location, education, experience, and skillset).