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Clinical Research Assoc II

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Clinical Research Assoc II

  • 2020-16905
  • Redmond, Washington, United States

The Clinical Research Associate is responsible for conducting clinical trials on company products. The incumbent implements and documents clinical evaluations of diagnostic products to verify product claims, comply with FDA requirements.

Responsibilities

  • Coordinates tasks to implement clinical trials; plans, organizes, instructs, troubleshoots and monitors clinical trials according to approved clinical protocols to ensure that study objectives are achieved.
  • Prepares / revises study designs, protocols, protocol addendums and Study reports.
  • Supervises the collection and organization of clinical trial data; prepares clinical data summary reports for regulatory submission.
  • Audits investigator performance to ensure compliance with agreements, clinical protocol, and FDA regulations.
  • Communicates and interacts with other departments (Regulatory Affairs, Research & Development, and Marketing) to facilitate product transfer to clinical trials.
  • Keeps management informed of project status and planned activities; attends meetings and makes presentations as required; may be assigned to a project team.
  • Performs in-house experiments to support clinical research activities. Participates in the design and performance of preclinical studies to ensure that specifications are met and establish acceptable value ranges.

Qualifications

Education: B.A. / B.S. degree or equivalent in biological sciences. Medical Technology certification desirable.

Experience: Minimum 2 years experience in clinical research / clinical monitoring, with full knowledge of ICH/GCP guidelines and FDA regulations and guidelines. Previous experience with in vitro diagnostic or medical device industry and / or experience in a clinical laboratory are preferred.

Skills: Ability to communicate with professional medical personnel. Excellent oral and written communication skills as well as proficiency with relevant computer software (Microsoft Office). Ability to travel including international.  Full knowledge of ICH/GCP guidelines and FDA regulations and guidelines.  Strong critical/analytical thinking and problem solving skills.  The ability to work within a team environment. Detail oriented.

About Bio-Rad:

Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.

 

Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.

 

EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age

To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

 

 

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