Clinical Research Scientist

About Company

Mizuho OSI is the leader in the markets for specialty surgery and patient positioning. The company’s portfolio includes specialty surgical tables for procedure-specific approaches that improve patient outcomes in spine and orthopedic surgeries along with disposable and reusable surgical patient care products.

Job Summary

As the Clinical Research Scientist, you will be responsible organizing, overseeing, and supporting clinical studies or trials that contribute to improving outcomes for people undergoing surgery.

The Clinical Research Scientist will be responsible for proposing, planning, organizing, and executing clinical research. This position will assume the lead role in clinical research projects and will interact with scientists and healthcare professionals within and outside of the organization. The Clinical Research Scientist will summarize findings in reports and communicate results. This position will work with the Marketing team to implement team initiatives and projects.

Responsibilities

• Develop, organize, monitor, and oversee clinical research studies and associated roadmap. Support and assist with all clinical studies and research.
• Provide strategic input and development support for clinical plans and individual study protocols.
• Develop research-related documents including study protocols, study materials, SOPs, and study procedures.
• Develop and implement standard operating procedures for all aspects of clinical research, reporting, and assuring compliance with regulatory requirements, as required.
• Demonstrate appropriate technical proficiency, scientific creativity, collaboration with others and independent thought.
• Maintain specific records of research activity to include regulatory forms, case reports, and consent forms, as required.
• Analyze, test, and report clinical data and results. Conduct qualitative and quantitative analyses of research data. Develop statistical plans and perform preliminary and exploratory data analysis of completed clinical trials.
• Develop study reports, scientific abstracts, peer-reviewed manuscripts, and grant proposals. Prepare final reports and occasional manuscripts or publication.
• Review results of clinical evaluations with management prior to implementation.
• Provide customer and staff support with clear communication of clinical data.
• Understand Mizuho OSI’s business objectives and the relationship between the Department and those objectives; to support and follow the Corporate Vision, Mission & Values Statements, to maintain the services and quality levels set by Mizuho OSI, and to continually enable Mizuho OSI to be a great place to work.
• Understand, follow and support Mizuho OSI’s internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards).
• Other duties as assigned.
  
  

Qualifications & Requirements

• Requires 1 to 3 years of directly related experience and Master's or PhD degree in scientific discipline requried.
• Work experience in the Medical Device industry is a plus.
• Ability to use Microsoft products such as Outlook, Word, Excel, and PowerPoint.
• Knowledge of statistical data collection, validation, editing and analysis techniques.
• Knowledge of laboratory certification processes and standards, as required.
• Ability to provide technical guidance, advice and support to professional staff where needed.
• Superior problem solving, deductive reasoning and decision-making skills.
• Ability to be agile with change in direction.
• Ability to manage multiple priorities simultaneously
• Ability to work effectively in a fast-paced culture.
• Ability to organize work effectively, set priorities, provide attention to detail, and ability to maintain detailed and accurate records.
• Ability to establish and accomplish goals independently and to function as a positive and productive team member.
• Ability to build effective relationships with clinical trial center staff.
• Excellent customer focus with a high sense of urgency and excellent interpersonal and communication skills.
• Excellent verbal and written communication skills, strong presentation, project, and organizational skills.
• Ability to travel up to 30%.
  
  

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Salary Range: $98,000 - $126,000 DOE + potential annual bonus + comprehensive benefits package