Clinical Research Associate

Job Description

Join our dedicated team as a Clinical Research Associate where you will manage clinical trials, ensuring compliance with regulatory guidelines and protecting participant welfare. You will collaborate with multi-disciplinary teams and contribute significantly to innovative research projects that aim to improve healthcare worldwide.

Responsibilities

• Monitor site performance and compliance throughout study duration.
• Facilitate communication between investigators and the sponsor.
• Review informed consent processes to ensure participant understanding.
• Report adverse events and ensure safety monitoring.
• Assist in the development of study protocols and manuals.
• Participate in project team meetings and provide updates.
• Prepare for regulatory inspections and audits as needed.
• Conduct training for investigators and study coordinators.
• Organize and file study documentation systematically.
• Identify and troubleshoot issues at study sites proactively.

Requirements

Education

• Bachelor's degree in a health-related field
• Additional certifications in clinical trial management is a plus

Experience

• 2+ years of experience as a CRA or similar position

Technical Skills

• Protocol Design
• Regulatory Compliance

Soft Skills

• Organizational Skills
• Interpersonal Skills

Certifications

• Good Clinical Practice (GCP) Certification

Languages

• English: Fluent

Advantageous

• Familiarity with the South African clinical research environment: Experience working with local ethics committees and regulatory authorities.
• Publication experience: Experience in authoring or co-authoring clinical research publications.