CV BANK- CRA II - In-Vitro Diagnostics

ICON is looking for a CRA II with IVD ( in vitro diagnostics) POC  experience! 

Responsibilities:

The Clinical Research Associate (CRA) will lead in designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics. Responsibilities include:

• Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements;
• Validating product performance claims;
• Supplying data for critical Regulatory submissions;
• Defining the functional and clinical utility of investigational products, and
• Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders.

• Performing or coordinating aspects of external clinical studies including site selection, study initiation, site monitoring, and study closeout.
• Maintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are met.
• Interfacing with staff to support post launch activities.
• Reviewing cases with investigators to resolve discrepancies.
• Understanding and implementing federal regulations, helping to develop standard operating procedures in order to ensure that 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 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 to analyze and solve problems
• Demonstrated experience in computer skills to include Microsoft Word, Excel, and basic templates
• Statistical knowledge
• Supervision experience or experience in a leadership role preferred

Minimum - Bachelor's degree in relevant field. Medical technology degree preferred, but not required if R&D background is adequate

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, 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.

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.