Clinical Research Associate I

4 weeks ago

Hobart, Tasmania, Australia Pharmiweb Full time
Job Title: Clinical Research Associate I - Histologist

At ICON, we are committed to providing a comprehensive and competitive total reward package that comprises an excellent level of base pay, as well as a wide range of variable pay and recognition programs. Our best-in-class employee benefits, supportive policies, and wellbeing initiatives are tailored to support you and your family at all stages of your career.

We are seeking a highly skilled Clinical Research Associate I - Histologist to join our team. As a Histologist - CRA I, you will be responsible for leading and managing activities related to the design, coordination, and execution of clinical research studies focused on in vitro diagnostics. You will ensure clinical studies and monitoring visits are conducted and documented in compliance with study protocols, site monitoring SOPs, applicable regulations, and the principles of ICH/GCP as appropriate.

Key Responsibilities:

  • Lead and manage activities related to the design, coordination, and execution of clinical research studies focused on in vitro diagnostics.
  • Ensure clinical studies and monitoring visits are conducted and documented in compliance with study protocols, site monitoring SOPs, applicable regulations, and the principles of ICH/GCP as appropriate.
  • Validate product performance claims and support critical regulatory submissions.

Requirements:

  • Bachelor's degree in a relevant field.
  • At least 2 years of hands-on experience in histology.
  • Prior CRA experience is a plus.
  • Proficiency in histological techniques (e.g., sectioning, staining, immunohistochemistry).
  • Experience working with analyzers and diagnostic instruments.
  • Familiarity with specialized testing procedures and laboratory workflows.
  • Experience with laboratory information systems (LIS) or other data management software.
  • Ability to adapt to new systems and technologies efficiently.
  • Certification as a Histotechnician (HT) or Histotechnologist (HTL) by ASCP or equivalent preferred but not required.
  • Strong attention to detail and ability to troubleshoot technical issues independently.
  • Excellent communication and collaboration skills.

We are an equal opportunity and inclusive employer and are committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

We would encourage you to apply regardless of whether you meet all of the requirements. There's every chance you're exactly what we're looking for here at ICON.

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