The position provides clinical monitoring activities in support of assigned projects.
- 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.
- 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%).
Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.