CRA 2 - Brazil
On-siteSão Paulo, São Paulo, Brazil
Job Summary
Conduct site monitoring visits, including selection, initiation, monitoring, and close-out, ensuring adherence to Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Adapt and track subject recruitment plans to enhance predictability while administering protocol training and establishing communication lines with sites. Evaluate study site practices for protocol adherence and regulatory compliance, escalating quality issues as needed. Manage study progress by tracking regulatory submissions, recruitment, enrollment, case report form completion, and data query resolution. Maintain Trial Master File and Investigator's Site File documentation, submitting regular visit reports and follow-up letters. Collaborate with study team members to support project execution.
Required Qualifications
- Bachelor's Degree Degree in scientific discipline or health care
- Excellent command of English (written/spoken)
- Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
- Strong attention to detail
- Excellent communication skills
- Exceptional problem-solving, judgment, and decision-making abilities
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
- Organizational and problem-solving skills
- Effective time and financial management skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Desired Qualifications
- Good therapeutic and protocol knowledge as provided in company training
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