Study Coordinator

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).