Clinical Research Associate

Job Description

We are seeking a Clinical Research Associate to join our innovative research team in Johannesburg. This role involves overseeing clinical trials, collaborating with multiple stakeholders, and ensuring compliance with regulatory requirements. The ideal candidate will possess strong analytical skills and a passion for advancing medical research.

Responsibilities

• Ensure clinical trials are conducted in compliance with regulatory requirements.
• Conduct ongoing assessments of site performance and data integrity.
• Maintain timely and accurate trial documentation.
• Communicate with stakeholders regarding study progress and updates.
• Oversee data collection to ensure accuracy and completeness.
• Assist in the preparation for audits and regulatory inspections.
• Train and mentor site staff throughout the trial process.
• Facilitate patient recruitment strategies and engagement.
• Draft and review study-related documents and reports.
• Ensure timely reporting of adverse events and notable findings.

Requirements

Education

• Bachelor's degree in Health Sciences or Nursing
• Master's degree in Clinical Research or similar field is preferred

Experience

• 3-5 years of experience in clinical trials management

Technical Skills

• Regulatory Compliance
• Statistical Analysis

Soft Skills

• Analytical Skills
• Team Leadership

Certifications

• Clinical Research Coordinator (CRC)
• GCP and ICH Certification

Languages

• English: Fluent
• Zulu: Conversational

Advantageous

• Familiarity with international clinical trial guidelines.: Understanding of ICH-GCP guidelines and other regulatory frameworks.
• Experience with statistical data analysis tools.: Proficiency in tools used for analyzing clinical trial data sets.

Benefits

• Health insurance plans including mental health support
• Generous leave policies including study leave
• Employee wellness programs and resources
• Opportunities to attend international conferences

Company Culture

• Diversity and Inclusion: We value diversity in our workforce and create an inclusive environment for all.
• Empowerment: We empower employees to take initiative and lead within their roles.
• Community Engagement: We believe in giving back to the community through outreach and involvement in health initiatives.