Clinical Research Associate (CRA)

Primary Function:

The position provides clinical monitoring activities in support of assigned projects.

Job Description:

• Independently perform site visits in compliance with SOPs.
• Conduct routine site contacts to ensure site compliance, adequate enrolment, and understanding of study requirements.
• Review and verify case report forms and other clinical data for completeness and accuracy.
• Interpret data to identify protocol violations or major risks to patient safety or data integrity.
• Generate queries and manage resolutions with site personnel.
• Maintain project tracking systems as required.
• Identify and resolve minor site issues independently while escalating and participating in the resolution of more complex issues.
• Complete assigned training programs and apply learning.
• Performing administrative tasks.

Experience Required:

• Two years prior clinical monitoring experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Strong organizational skills.
• Must demonstrate good computer skills.
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Ability to travel as necessary (approximately 60%).

Education Required:

Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.