Associate II, Pre Clin Res - 100950 - San Jose,CA - 0300 – Fremont

The Pre-Clinical Research Associate is a specialist level position responsible for study design, execution, planning and management of a project. This position requires an analytical interpretation and demonstrated ability for study design, execution, planning and management. The Research Associate II is learning and developing an analytical skill set resulting in study reports recommendations and supporting regulatory submissions.

Duties and Responsibilities:
Role: Researcher:

• Understand scientific rationale for species selection
  
• Demonstrate creativity to suggest design to PC Management which meets study objectives
  
• Understand study requirements and act on recommendation from management
  
• Knowledge of study design, intent and rationale
  
  Role: Study Coordinator:
  
• Site selected independently through competitive bidding process
  
• Approved initial study documentation with management input
  
• Study documentation completed with management input
  
• Independently obtain materials for completion of study
  
• Independent scheduling study within project timeline; study expectations communicated to core team through director level and CRO: allocation of resources within or under budget
  
• Independent data compilation
  
  Role: Report Writer:
  
• Study data alignment with study objectives requiring limited coaching
  
• Analysis of study data contributing to project decisions with management coaching
  
• Independent compilation of study analysis and report draft with mentoring from SRA or above
  
  Role: Client Advisor:
  
• Analysis of study data and limited interpretation with mentoring
  
• Receives internal/departmental consultation on study design and endpoints
  
• Discuss study endpoints to address risk mitigation and safety
  
• Discuss endpoints to impact project decisions
  
  Role: Mentor/Mentee
  
• Receives mentorship and coaching from others
  
  Role: Quality Champion
  
• Complaint reporting
  
• Identify CAR/CAPA. Execute CAR/CAPA
  
• Ensure up to date training
  
  Minimum Education & Experience:
  Bachelors Degree in Biology or Veterinary Technology. Professional Experience: 2-4 years, Biology or Veterinary profession. Some travel (10-30%) to research laboratories, meetings, and/or other BSC facilities. Strong communication skills with the ability to build solid relationship across all levels of the organization. Proactive problem solving skills contributing to continuous process improvements. Medical device experience highly desired.
  
  Apply Here