Coordinator, Clinical Research

Overview

Find a Better Way...

 

...to use your skills and experience.

This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way.

 

...to improve the lives of others.

Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.

 

...to build a promising future. 

Responsibilities

We currently have a great opportunity available for a Clinical Research Coordinator. The Coordinator, Clinical Research supports the planning, execution, and management of clinical studies under the guidance of senior CRAs and project managers. This entry-level role ensures regulatory compliance, accurate documentation, and smooth site operations while gaining hands-on experience in clinical research processes.

 

Essential Duties and Responsibilities:

 

1. Assist the CRA to prepare, review, and maintain clinical study documents, including but not limited to Study protocols, Informed Consent Forms, Clinical Study Reports, and Regulatory documents (Investigator Notebook, Master Notebook, Sponsor Notebook), ensuring completeness and accuracy.2. Assist with Site Qualification, Site Initiation, Interim Monitoring, and Close-out Visits under supervision, ensuring sites meet regulatory and study requirements.3. Monitor clinical studies data under the supervision of a Sr CRA to ensure adherence to study protocols and maintain data integrity. 4. Assist the CRA in all aspects of clinical study site management, including site staff training5. Monitor data in the Electronic Data Capture (EDC) system under the supervision of a CRA, review e-CRF, track enrollment status, and alert leadership to emerging issues.6. Coordinate logistics for site activities, including study supply shipments, study communications, and site visit scheduling7. Support regulatory and legal processes, including initiation of Non-Disclosure Agreements (NDAs), Clinical Study Agreements (CSAs), Supplier/Vendor qualification, and budget tracking. 8. Ensure compliance with GCP, ICH, ISO 14155, and other applicable regulations and company policies.9. Knowledge of regulations and standards affecting Sysmex products. Comply with all policies, established procedures, and applicable regulations related to clinical research. 10. Other duties, as needed.

 

Physical Risk: Regular exposures to risk that may require special training and precautions. 

Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions. 

Percentage of Travel: 20%

Qualifications

• Bachelor’s degree in Life Sciences or equivalent and a minimum of 0-2 years of clinical research experience. Basic understanding of clinical research principles, GCP, and regulatory requirements.
• Experience working directly with clinical investigators and study sites.
• Thorough understanding of applicable regulations, including but not limited to 21 CFR Parts 50, 54, 56, 58 and ICH E6, and requirements for in vitro diagnostic devices.
• English
• Computer literacy to operate standard word processing, spreadsheets, presentation and internet application.
• Good foundation in laboratory testing methodologies.
• Effective verbal and written communication skills.
• Ability to manage multiple tasks and work collaboratively in a team environment.
• Detail-oriented with strong prioritization skills.
• Effective time management skills.

This job requires satisfaction of the credentialing requirements of Sysmex’s customers, including hospitals and other healthcare facilities, which generally includes proof of current vaccinations for measles, mumps, rubella, varicella (chicken pox), and COVID-19.  Further, Sysmex’s COVID-19 vaccination policy, consistent with its status as a federal government contractor and commitment to its customers and to providing a safe workplace for its employees, requires