CV BANK- CRA I- Histologists

Icon - Remote, OR

Full-time - Mid Level

Remote, OR

Professional, Scientific, and Technical Services

About the position

The Clinical Research Associate (CRA) position at ICON is designed for individuals transitioning from a Histologist role. The CRA will be responsible for leading and coordinating clinical research studies related to in vitro diagnostics, ensuring compliance with regulatory standards and study protocols. This role involves significant interaction with study investigators and key opinion leaders, as well as oversight of study activities from initiation to completion.

Responsibilities

• 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.
• 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.

Requirements

• 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.

Nice-to-haves

• CRA certification by recognized professional organization is a plus, but not mandatory.
• Supervision experience or experience in a leadership role preferred.

Benefits

• Comprehensive and competitive total reward package including base pay and variable pay.
• Best in class employee benefits.
• Supportive policies and wellbeing initiatives tailored to support employees and their families.
• Commitment to continuous learning and professional development.