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.
We currently have a great opportunity available for a Clinical Research Sr. Associate. The overall purpose of this position is to be responsible for designing, implementing, and monitoring clinical studies of new and modified Sysmex products. Prepares clinical protocols, study progress reports, clinical trial reports, and data summaries. Supports preparation of clinical section of regulatory submissions.
Essential Duties and Responsibilities:
Knowledge of regulations and standards affecting Sysmex products. Complies with all polices, established procedures, and regulations related to clinical research, including 21CFR Parts 50, 56 & 58.
Prepares clinical protocol, informed consent, clinical trial report, and other required documents for clinical studies. Assists with responses to regulatory agency questions pertaining to clinical studies.
Initiates legal documents including Non-disclosure Agreements and Clinical Trial Agreements. Proposes and negotiates budgets for clinical studies. Initiates and track payments to sites ensuring budget adherence.
Qualifies clinical investigators. Obtains and reviews all required essential documents necessary for study initiation.
Initiates clinical studies and provides investigator and staff training. Monitors clinical studies, 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.
Assists Data Management and Statistics with the collection and querying of clinical data and tracking of enrollment at the clinical sites
Actively participates as a member of cross-functional project teams.
Assists in training newly hired CRAs.
Prepares study updates to keep management informed.
Other duties, as required.
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.
Minimum Bachelor's Degree in science related field, or equivalent and 5-7 years of Clinical Research experience required. Medical Technology background preferred.
Experience working directly with clinical investigators and study sites.
Thorough understanding of FDA regulations and requirements for in vitro diagnostic devices.
Good foundation in laboratory testing methodologies.
Effective verbal and written communication skills.
Computer literacy to operate standard word processing, spreadsheets, presentation and internet application.
Detail oriented with strong prioritization skills.
Ability to travel up to 40% of time.
Effective time management skills.
Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of sex, sexual orientation, gender identity, color, religion, national origin, disability, protected Veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.