Clinical Research Associate I

2 weeks ago

Darwin, Northern Territory, Australia Pharmiweb Full time
Job Title: Clinical Research Associate I - Histologist

ICON is seeking a highly skilled and motivated Clinical Research Associate I - Histologist to join our team. As a Clinical Research Associate I - Histologist, you will be responsible for leading the design, planning, coordination, and conduct of clinical research studies for in vitro diagnostics.

Responsibilities:
  • Ensure studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices, and other applicable regulatory requirements.
  • Validate product performance claims.
  • Supply data for critical regulatory submissions.
  • Define the functional and clinical utility of investigational products.
  • Obtain opinions and input regarding investigational products from laboratories or customers.
  • Perform or coordinate aspects of external clinical studies, including site selection, study initiation, site monitoring, and study closeout.
  • Maintain communication with study investigators to ensure studies are completed in a timely fashion and study objectives are met.
  • Interface with staff to support post-launch activities.
  • Review cases with investigators to resolve discrepancies.
  • Understand and implement federal regulations, helping to develop standard operating procedures to ensure studies adhere to FDA regulations, Good Clinical Practices, IVD directives, policies, and procedures.
Qualifications:
  • 5 years of experience as a Clinical Research Associate, with specific in vitro diagnostics study experience preferred.
  • CRA certification by a recognized professional organization is a plus, but not mandatory.
  • Excellent oral and written communication skills.
  • Excellent planning, organizing, interpersonal, and leadership skills.
  • Ability to work independently to make sound decisions and analyze and solve problems.
  • Demonstrated experience in computer skills, including Microsoft Word, Excel, and basic templates.
  • Statistical knowledge.
  • Supervision experience or experience in a leadership role preferred.
Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay but also a wide range of variable pay and recognition programs. In addition, 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 - both now and into the future.

Our success depends on the knowledge, capabilities, and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

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