Specialist, Senior Hemostasis Clinical

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 Senior Hemostasis Clinical Specialist. Works in concert with the Assistant Director, Hemostasis in the development of the pre-clinical and/or clinical activities for Hemostasis products leading to regulatory clearance in the Americas. The Sr. Specialist is knowledgeable on pre-analytical and testing processes & will provide hemostasis expertise for development activities necessary for successful data collection and submission. The Sr. Specialist will be responsible for ensuring that clinical study sites adhere to Good Clinical Practice (GCPs), Standard Operating Procedures (SOPs), and study protocols. The Sr. Specialist will assist with writing protocols and implement studies for new hemostasis products and shall be responsible for multiple assays. The Sr. Specialist shares responsibility for data collection, management, integrity, completeness, accuracy, legibility and analysis for preparation of FDA submission.

 

 

Essential Duties and Responsibilities:

1. Works in concert with the Assistant Director, Hemostasis in development of and pre-clinical/clinical activities for products being designed and developed for Coagulation marketplace. The Senior Specialist, will also provide expertise needed for development of activities necessary for successful data collection and submission of instrument(s) and assays.2. Considered knowledgeable in coagulation pre-analytical and testing process. Acquires a complete understanding of methodology & principles of new instruments and assays. Develops “hands-on” knowledge and skills in performing assigned assays, becomes SME for Sysmex CN-series instruments. 3. Responsible for multiple clinical trial processes and assists with: writing clinical trial protocols and standard operating procedures relating to coagulation IVD products, site selection, and completion of confidentiality agreements, contract negotiation, IRB approval, and the clinical trial data collection.4. Ensures site compliance with the clinical protocol, GCP guidelines, and protection of subject rights, safety and welfare.5. Works closely the Project Manager and CROs to ensure data collection, management, integrity, completeness, accuracy, legibility and analysis for preparation of FDA submission. 6. Monitors and support clinical FDA evaluations with multiple sites, including providing assistance with sample handling.7. Train and/or re-train site personnel to ensure successful study performance. Provide clinical site troubleshooting support during clinical trial.8. Plan and coordinate logistics for shipment of study related supplies and instruments to sites. Conducts on-site device/reagent accountability and reconciliation procedures.9. Attend/participate in training meetings on protocol, Standard Operating Procedures, Working Practice Documents, and other monitoring and administrative-related

10. Other duties and projects as may be assigned.

 

Percentage of Travel: Able to travel up to 50% of time; including short notice travel, as needed.

 

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.

Qualifications

• Bachelor’s Degree in Science (MLS), and 5 years Clinical Laboratory experience within the least 10 years OR• Associate of Science (MLT) plus 10 years’ Clinical laboratory experience within the last 15 years.• CRA or PMP experience (and/or certification) is a plus.• Comprehensive medical lab knowledge w/ emphasis in hemostasis Instruments & testing.• Good foundation in current laboratory testing methodologies across other departments.

• Documented prior/cu