Clinical Research Associate (CRA) Job Listing at Sysmex America, Inc. in Illinois, United

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 America 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.

We currently have a great opportunity available for a Clinical Research Associate (CRA). The CRA will work in concert with the Manager, Clinical Affairs and Coagulation Specialist (CS) in the development of and the pre-clinical and/or clinical activities for products being designed and developed for the Coagulation marketplace. The CRA monitors activities at clinical study sites to assure adherence to Good Clinical Practice (GCPs), Standard Operating Procedures (SOPs), and study protocols. This position will be responsible for implementing and monitoring clinical studies of new and modified Sysmex products and shall be responsible for multiple projects. This person prepares clinical data reviews and data summaries and provides customer support directly to health care professionals and hospitals. The position requires prior exposure to all aspects of a clinical study and functions at a proficient level of independence in conducting clinical research.

Essential Duties and Responsibilities:

1. Monitors activities at clinical studies for multiple projects, ensuring site compliance with the clinical protocol and GCP guidelines; assures subject rights, safety and welfare are protected; ensures data integrity through completeness, accuracy and legibility. This person will work with other team members in the design, planning, development and monitoring phases of clinical trials.

2. Prepares instructions for use, informed consents, and other required documents for clinical studies. Maintains regulatory binders at clinical sites and in-house.

3. Assists in qualifying clinical investigator and training of investigator and staff. Obtains and reviews all required essential documents necessary for study initiation

4. Conducts pre-study and/or clinical study, initiation, and closeout monitoring site visits and completes site visit reports. Maintains accurate and timely sponsor/site correspondence and communication. Provides study and instrument support to clinical trial sites.

5. Acquires a basic understanding of the principles of the assay and/or instrumentation and hands-on knowledge and skills in performing assigned assays or operating instruments.

6. Assists with data management and statistical analyses. Reviews data, prepares and presents clinical data reviews and data summaries.

7. Responds to audits and data queries. Coordinates logistics for shipment of study related supplies and instruments to sites. Conducts on-site device/reagent accountability and reconciliation procedures.

8. Train and/or re-train site personnel to ensure successful study performance. Provide clinical site troubleshooting support during clinical trial.

9. Attend/participate in training meetings on protocol, Standard Operating Procedures, Working Practice Documents, and other monitoring and administrative-related topics.

10. The above statement describes the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and additional responsibilities may be assigned as required by management.

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.

• English speaking required
• Ability to travel up to 50% of time.
• Word processing, spreadsheets with formulas, graphing and basic statistics.
• Effective verbal and written communication skills, Group Presentations, Data Summaries
• Laboratory /or LIS computer skills would be a plus.
• Good organizational and communication skills, effective project and time management skills.

• Minimum Bachelors Degree in Medical Technology, Life Science, or related field
• CRA (CCRA or SOCRA) certification preferred
• MT (ASCP) certification a plus.
• Minimum of 2 years CRA experience-- Medical devices preferred; Laboratory (hospital, research, industrial) 1-4 yrs or Clinical Research 2-3 yrs
• Knowledge of regulations and standards affecting in vitro diagnostic products.

We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing