Clinical Research Associate

Fremont, CA
Full Time
Entry Level

 

Description 

The Research Associate will perform immune monitoring assays for clinical samples and will participate in writing procedures (SOP/CSP).  This role plays a critical part in recording associated documentation relevant to the tasks at hand as per appropriate SOP and applicable GLP regulations and GCLP guidelines.

 

Responsibilities

  • Preparation and handling of primary specimens, including peripheral blood, ascites, and other liquid biospecimens
  • Isolation of white blood cells by density gradient separation
  • Sample preparation for immunostaining and acquisition by flow cytometry
  • Maintain all records and notebook, organize and compile QC data
  • Perform routine multi-color flow cytometry assays and cell-based assays supporting clinical trials according to Standard Operating Procedures including qualifications and validations as needed
  • Complete all paperwork thoroughly and accurately for QA/QC and GxP purposes using Good Documentation Practices and update computer-tracking systems, as required
  • Ensure lab maintenance activities and equipment calibration are performed according to schedule and maintain a clean and safe lab environment

 

Requirements

  • Bachelor of Science degree in Life Sciences, Immunology or Cell Biology
  • 1-2 years of relevant laboratory experience with basic laboratory skills
  • Ability to multi-task across multiple projects including a relatively high volume of clinical sample processing and analysis, using immunoassay techniques
  • Good organizational and documentation skills with superior attention to detail
  • Knowledge and understanding of working in a GLP/GCLP compliant regulatory laboratory to conduct experimental procedures per defined technical SOPs, with experience in handling biohazardous materials, and understanding safety procedures and guidelines

Preferred Knowledge, Skills & Abilities

  • Experience performing immunostaining and multi-color flow cytometry (8+ colors)
  • Knowledge in human blood sample processing and cell cryopreservation techniques, cell culture methods, cellular staining procedures using flow cytometry
  • Experience in aseptic techniques for handling primary human cells and for mammalian cell culture
  • Industry experience working with pre-clinical and clinical samples


Physical Demands and Work Environment

  • Must be able to sit and use hands to finger, handle, and feel
  • Must be able to lift and move packages weighing up to 50 pounds
  • Must be able to sit for long periods of time using a computer in a typical office environment in a multi-level facility
  • Some activities require repetitive motion and reaching, pulling, or pushing
  • In carrying out the duties of the job there will be frequent exposure to fumes and chemical hazards
  • Duties performed routinely require exposure to blood, body fluid, and tissue

 

 

All applicants are considered for all positions without regard to race, religion, color, sex, gender, sexual orientation, pregnancy, age, national origin, ancestry, physical or mental disability, medical condition, military or veteran status, genetic information, marital status, ethnicity, citizenship or immigration status or any other protected classification, in accordance with applicable federal, state, and local news. By completing this application you are seeking to join a team of hardworking professionals dedicated to consistently delivering outstanding service to our customers and contributing to the financial success of the organization, its clients, and its employees. Equal access to programs, services, and employment is available to all qualified persons.

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