CRA Sr CRA
Buenos Aires - Argentina
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
- Conduct on-site and remote monitoring visits using a risk-based monitoring approach.
- Review source documentation case report forms (CRFs) and study data to ensure accuracy completeness and compliance.
- Perform site management activities including site initiation routine monitoring and close-out visits.
- Assess investigational product accountability through inventory and records review.
- Identify site process issues perform root cause analysis and support implementation of corrective and preventive actions.
- Ensure essential documents are maintained in accordance with ICH-GCP and regulatory requirements.
- Prepare monitoring reports follow-up letters and study documentation within established timelines.
- Maintain effective communication with investigational sites sponsors and internal study teams.
- Support site identification feasibility and investigator engagement activities when applicable.
- Track study progress and maintain accurate records in clinical trial management systems (CTMS) and other study tools.
- Support regulatory inspections audits and quality initiatives.
- Contribute to process improvements project deliverables and knowledge sharing across teams.
- Bachelors degree in Life Sciences Nursing or a related healthcare field or an equivalent combination of education and experience.
- Valid drivers license where applicable.
- Ability to travel as required.
- Relevant clinical research and/or clinical monitoring experience in a pharmaceutical biotechnology CRO or healthcare environment.
- Candidates may be considered for CRA or SrCRA opportunities based on their experience qualifications and demonstrated monitoring expertise.
- Knowledge of ICH-GCP guidelines clinical trial processes and applicable regulations.
- Understanding of medical terminology and therapeutic areas.
- Strong critical thinking problem-solving and root cause analysis skills.
- Experience with Risk-Based Monitoring (RBM) methodologies.
- Excellent organizational and time management skills.
- Strong written and verbal communication skills including professional interaction with investigators and site personnel.
- Ability to work independently and collaboratively in a global team environment.
- Proficiency with Microsoft Office and clinical trial systems.
- Strong attention to detail and commitment to quality.
- English proficiency required.
Required Experience:
Senior IC
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more