Description
IQVIA Biotech is seeking a Senior Clinical Research Associate (CRA) to work in Brazil, preferably with oncology experience.
As a Sr. CRA, you will perform monitoring and site management work to ensure that sites are conducting studies and reporting study 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 channels
- Evaluating the quality and integrity of 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 that the Investigator's Site File (ISF) is maintained according to GCP and local regulations
- 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