Description
IQVIA Biotech is seeking a Senior Clinical Research Associate (CRA) in Argentina, preferably with oncology experience.
As a Sr. CRA, you will perform monitoring and site management work to ensure sites are conducting studies and reporting data according to the study protocol, regulations, guidelines, and sponsor requirements.
Key responsibilities include:
- Conducting site monitoring visits (selection, initiation, monitoring, and close-out) in accordance with the contracted scope of work and Good Clinical Practice
- Working with sites to adapt, drive, and track subject recruitment plans to enhance predictability
- Providing protocol and study-related training to assigned sites and establishing regular communication lines to manage project expectations and issues
- Evaluating study site practices and escalating quality issues as needed
- Managing study progress by tracking regulatory submissions, recruitment, case report form completion, and data query resolution
- Ensuring site documents are available for filing in the Trial Master File (TMF) and verifying Investigator's Site File (ISF) maintenance
- Creating and maintaining documentation regarding site management, monitoring visit findings, and action plans
Requirements:
- Bachelor's degree in a scientific discipline or healthcare (preferred)
- At least 3-4 years of on-site monitoring experience
- Equivalent combinations of education, training, and experience may be considered
- Good knowledge of and skill in applying applicable clinical research regulatory requirements