Clinical Research Associate II

3 weeks ago


Adelaide, South Australia Pharmiweb Full time
Job Title: Clinical Research Associate II

We are seeking a highly skilled Clinical Research Associate II to join our team. As a CRA II, you will be responsible for leading the design, planning, and execution of clinical research studies for in vitro diagnostics.

Responsibilities:
  • Ensure studies are conducted and documented in accordance with the study protocol, standard operating procedures, and regulatory requirements.
  • Validate product performance claims and supply data for critical regulatory submissions.
  • Define the functional and clinical utility of investigational products and obtain opinions from key opinion leaders.
  • 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 timely completion of studies and meet study objectives.
  • Interface with staff to support post-launch activities and review cases with investigators to resolve discrepancies.
  • Understand and implement federal regulations and develop standard operating procedures to ensure studies adhere to FDA regulations, Good Clinical Practices, and IVD directives.
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, planning, organizing, interpersonal, and leadership skills.
  • Ability to work independently, make sound decisions, and analyze and solve problems.
  • Demonstrated experience in computer skills, including Microsoft Word, Excel, and basic templates.
  • Statistical knowledge and supervision experience or experience in a leadership role preferred.
Why Join Us?

We offer a comprehensive and competitive total reward package, including a wide range of variable pay and recognition programs, best-in-class employee benefits, and supportive policies and wellbeing initiatives. Our focus is on developing our employees in a continuous learning culture, where every experience adds to your professional development.

We are an equal opportunity and inclusive employer, 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.



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