Clinical Research Associate II

2 weeks ago

Emelle Alabama, United States Pharmaceutical Research Associates, Inc Full time
Job Title: Clinical Research Associate II - In Vitro Diagnostics Specialist

We are seeking a highly skilled Clinical Research Associate II to join our team as an In Vitro Diagnostics Specialist. As a key member of our clinical research team, 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, good clinical practices, and other applicable 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 and input 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 studies are completed in a timely fashion and study objectives are met.
  • 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, 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, 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 and supervision experience or experience in a leadership role preferred.
  • Minimum - Bachelor's degree in a relevant field, medical technology degree preferred, but not required if R&D background is adequate.
Why Join Our Team?

We offer a comprehensive and competitive total reward package that comprises an excellent level of base pay, 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 committed to developing our employees in a continuous learning culture, where we challenge you with engaging work and every experience adds to your professional development. ICON, including subsidiaries, is an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment.

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