Clinical Research Associate

Job Description

The Clinical Research Associate position involves overseeing clinical studies from inception to completion. You will ensure adherence to protocol, assess site performance, and liaise between teams to ensure research objectives are met efficiently and ethically.

Responsibilities

• Ensure adherence to Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
• Coordinate all aspects of clinical trials from inception through completion.
• Conduct document reviews and audits to verify data integrity.
• Assist in the recruitment and assessment of clinical trial participants.
• Provide necessary support during site audits and inspections.
• Develop and implement corrective action plans as required.
• Facilitate training for site staff on protocol requirements and clinical trial procedures.
• Draft and submit reports of findings from site evaluation and monitoring.
• Engage with stakeholders to address and resolve operational issues.

Requirements

Education

• Bachelor’s degree in Life Sciences or a related field
• Master’s degree is preferred

Experience

• 2+ years of experience in clinical research or related fields

Technical Skills

• Clinical Research
• Data Analysis

Soft Skills

• Attention to Detail
• Communication Skills

Certifications

• Certified Clinical Research Associate (CCRA)
• Good Clinical Practice (GCP) Certification

Languages

• English: Fluent

Advantageous

• Experience with electronic data capture (EDC) systems: Familiarity with EDC tools like Medidata or Veeva is a plus.
• Knowledge of regulatory submissions: Understanding of the submission process for clinical trials.

Benefits

• Competitive salary with performance-based bonuses
• Medical aid and retirement plans
• Ongoing training and professional development
• Flexible working environment

Company Culture

• Teamwork: We value collaboration and foster a supportive environment.
• Innovation: We encourage innovative thinking and creativity in our projects.
• Commitment to Excellence: We strive for the highest quality in our research activities.