Senior Clinical Research Associate – FSP

This is a fully remote position, open to applicants in Brazil.

📋 Description

• The Senior Clinical Research Associate (SrCRA) is accountable for overseeing the execution of studies at designated sites.

• Serves as the primary liaison with the study site and is tasked with monitoring the conduct of the study.

• Responsible for the preparation, initiation, monitoring, and closure of assigned sites within clinical trials.

• Participates in the selection of potential investigators.

• Initiates, oversees, and concludes study sites in accordance with the client’s Procedural Documents.

• Updates the Clinical Trial Management System (CTMS) and other platforms with site data according to established timelines.

• Manages study materials (ISF, etc.), drug supplies, and ensures drug accountability at the study site.

• Conducts monitoring visits (both remote and onsite) and performs remote data checks, adhering to the timelines outlined in the study-specific Monitoring Plan.

• Follows up on any outstanding actions with study sites to ensure timely resolution.

⛳️ Requirements

• A Bachelor’s degree in a related field, preferably in life sciences, or an equivalent qualification.

• Strong understanding of international guidelines ICH-GCP and basic knowledge of GMP/GDP.

• Familiarity with relevant local regulations.

• Solid medical knowledge and the capacity to learn about the client’s Therapeutic Areas.

• Fundamental understanding of the drug development process.

• Good grasp of Clinical Study Management, including monitoring, study drug handling, and data management.

• Exceptional attention to detail.

• Strong written and verbal communication abilities.

• Effective collaboration and interpersonal skills.

• Proficient negotiation skills.

• Ability to travel nationally/internationally as needed.

🏝️ Benefits

• Health insurance

• Flexible working arrangements

• Professional development

• Paid time off