Study Coordinator I

Altasciences; Columbia Township (MO); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Health/Dental/Vision Insurance

401(k) with Employer Match

Paid Vacation and Holidays

Paid Sick Leave

Employee Assistance & Telehealth

Telework when applicable

Training & Development Programs

Employee Referral Bonus

Job summary

Altasciences is seeking a Study Coordinator to plan, execute, and report nonclinical studies under the guidance of Study Directors. You will coordinate study administration, scheduling, documentation, compliance monitoring, and cross-functional alignment with SOPs and regulatory guidelines.

You will assist with protocol preparation, participate in protocol reviews, monitor data collection in the EDC system, and help prepare study reports and final deliverables.

Qualifications

• Bachelor's degree in a scientific discipline with 0–1 year experience
• MS Office Suite
• Ability to read and interpret technical documents and industry manuals
• Ability to write advanced documents and correspondence
• Ability to speak effectively before groups
• French language proficiency may be required depending on location
• Ability to multi-task and stay organized in a fast-paced environment
• Strong planning and organizational skills
• Ability to work well in a team under time pressure
• Attention to detail and accuracy

Responsibilities

• Assist with preparation, review, and distribution of study protocols and amendments; may draft study documentation
• Coordinate protocol review, pre-initiation, and study-related meetings
• Review study schedules for data collection in the electronic data capture system and manage amendments
• Create and maintain study planning documents such as project review forms and outlines
• Prepare and maintain study notebooks, forms, and materials
• Support day-to-day study activities across functional departments
• Track study progress, milestones and deliverables; communicate status to directors and sponsors
• Review data for accuracy and compliance; identify discrepancies and escalate deviations
• Generate data tables for reports and perform data verification
• Coordinate studies from initiation to finalization with increasing responsibility
• Support monitoring activities for non-GLP and GLP studies as appropriate
• Assist in drafting sections of study reports and peer-review processes
• Collect and collate report components for final reports
• Maintain audit-ready study documentation and files
• Assist with archiving and finalization preparation
• Support QA activities including audits and response coordination
• Coordinate client interactions and visits; serve as a key liaison
• Provide backup support to Study Directors as needed
• Prepare and verify sample manifests and coordinate shipping/inventory

Skills

MS Office

Technical reading

Technical writing

Public speaking

French

Education

Bachelor's degree in science

Tools

Electronic data capture system

Job description

About The Role

The Study Coordinator Isupportsand coordinates the planning, execution, and reporting of nonclinical studies under the guidance of Study Director(s). This roleis responsible forstudy administration, scheduling, documentation, compliance monitoring, and cross-functional coordination to ensure studies are conductedin accordance withprotocols, standard operating procedures (SOPs), and regulatory guidelines.

What You’ll Do Here

• Assistwith the preparation, review, and/or distribution of study protocols, and amendments; with experience, may independently draft study documentation.
• Coordinate and/orparticipatein protocol review, pre-initiation, and study-related meetings.
• Review study schedules for data collection within the electronic data capture system. Review updated schedule changes as a result of Amendments/Amended Protocols, as necessary based on site structure.
• Assist in the creation, review, and maintenance of study planning documents (e.g., Project Review Forms or study outlines) under guidance, based on site structure.
• Assist with preparation and maintenance of study notebooks, study forms, and other necessary materials for studies, based on site structure.
• Support and coordinate day-to-day study activities across functional departments to ensure alignment with study plans
• Track study progress, milestones, and deliverables; communicate status updates to Study Director(s) and stakeholders (i.e. In-Life personnel, study support groups, sponsors).
• May review study data, records, and processes for accuracy, completeness, and compliance with protocols, SOPs, GLP, and regulatory requirements. Identifydiscrepancies, coordinate resolution of data issues, and elevate deviations toStudyDirector(s).
• May generate data tables for inclusion in reports based on requirements of the study. Perform data verification as needed based on site structure.
• Provide coordination for assigned studies from initiation through finalization, based on site structure, with increasing responsibility over time.
• Support orassistin monitoring in-life study activities asappropriate. Support ongoing compliance monitoring throughout the lifecycle of the study.
• May assist in the preparation, compilation, and formatting of study reports, including drafting sections (e.g., Materials and Methods) and peer review process based on site structure.
• Collects and collates report components for the final report under the guidance of the Study Director utilizing electronic publishing tools based on site structure.
• Maintainaccurate, organized, and audit-ready study documentation, including study files, schedules, and correspondence.
• May support archiving and preparation of studies for finalization.
• Assistwith quality assurance activities, which may include audit preparation and response coordination.
• Support Study Director(s) in coordinating and preparing for client interactions and visits, based on site structure. May serve as a key point of contact for internal communication across departments for assigned study activities.
• Provide coordination for short term, acute, non-GLP studies from study initiation to finalization under the guidance of the Study Director. May also be responsible for coordination for GLP studies.
• Provide backup support to Study Director(s) as needed, including communicating study status to stakeholders.
• May prepare and verify sample manifest, and coordinate shipping and inventory of samples.

What You’ll Need to Succeed

• A Bachelor’s degree or college coursework in a scientific discipline with 0 - 1 years experience in a scientific environment or an equivalent combination of education and experience.
• 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 of the organization.
• Bilingual proficiency in French may be required, depending on location.
• Ability to multi-task and maintain organization 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 operate with accuracy and quality.

Work Authorization & Sponsorship

Applicants must be legally authorized to work in the United States. Altasciences is unable to provide sponsorship, sponsorship transfers, or visa maintenance for this position. All applicants must possess valid work authorization that does not require employer sponsorship now or in the future.

What We Offer

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Benefits

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences’ Benefits Package Includes:

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs
• Telework when applicable.

Altasciences’ Incentive Programs Include:

• Training & Development Programs
• Employee Referral Bonus Program