Senior Clinical Research Associate (CRA)

Placements24; Durban; Hybrid; ZAR 600,000 - 1,000,000; Full time

Benefits offered by this job

Competitive salary

Incentives

Health coverage

Retirement fund

Annual leave

Travel expenses

Professional development

Team environment

Job summary

Placements24 is seeking a Senior Clinical Research Associate to join its clinical operations team in Durban. The role focuses on site monitoring, data integrity, and regulatory compliance to ensure high-quality trial execution across multiple sites.

The successful candidate will have 4–6 years of CRA experience, strong ICH-GCP knowledge and proficiency with CTMS/EDC systems. Occasional travel to sites will be required, and the position offers a competitive package and professional development

Qualifications

• Bachelor's degree in a life science, nursing or related field.
• 4–6 years of CRA experience in pharma/biotech.
• Strong ICH-GCP knowledge and local regulatory requirements.
• Experience in site monitoring incl. initiation, routine and close-out visits.
• Willingness to travel up to 60%.
• Proficiency with CTMS and EDC systems.
• Excellent communication and organizational skills.

Responsibilities

• Conduct site initiation, interim monitoring and close-out visits.
• Manage designated number of clinical trial sites per protocol and SOPs.
• Maintain relationships with investigators and site staff.
• Verify data accuracy and integrity across sites.
• Resolve data queries and support trial documentation.

Skills

Site monitoring

ICH-GCP

CTMS

EDC

Communication

Teamwork

Travel readiness

Education

Bachelor's degree in Life Sciences

Tools

CTMS

EDC systems

Job description

About the Role

Our client, a globally recognized pharmaceutical company, is actively seeking a seasoned Senior Clinical Research Associate (CRA) to join their dedicated clinical operations team based in Durban, KwaZulu-Natal . This role is critical for ensuring the successful execution of clinical trials, maintaining data integrity, and adhering to all relevant regulatory guidelines and protocols. As a Senior CRA, you will play a key role in monitoring study sites, managing relationships with investigators and site staff, and ensuring patient safety. The ideal candidate will possess extensive experience in site management, monitoring, and a deep understanding of Good Clinical Practice (GCP) principles. This is an exciting opportunity to contribute to life-changing research in a vibrant coastal city.

Key Responsibilities

• Conduct site initiation, interim monitoring, and close-out visits to assess protocol compliance, data accuracy, and patient safety.
• Manage a designated number of clinical trial sites, ensuring adherence to study protocols, SOPs, and GCP guidelines.
• Build and maintain strong working relationships with investigators, site staff, and other study stakeholders.
• Verify the accuracy, completeness, and integrity of clinical data reported by study sites.
• Ensure timely resolution of data queries and discrepancies identified during monitoring visits.
• Prepare and present monitoring visit reports to the clinical trial team.
• Oversee drug accountability and ensure proper storage and handling of investigational products at trial sites.
• Identify, report, and escalation any potential study-related issues or risks to the clinical trial manager.
• Participate in the training of new CRAs and provide mentorship to junior team members.
• Ensure all regulatory documentation is complete, accurate, and filed appropriately.

Requirements

• Bachelor's degree in a life science, nursing, or related healthcare field.
• Minimum of 4-6 years of experience as a Clinical Research Associate in the pharmaceutical or biotech industry.
• In-depth knowledge of ICH-GCP guidelines and local regulatory requirements.
• Proven experience in performing site monitoring activities, including initiation, routine, and close-out visits.
• Strong understanding of clinical trial processes from study start-up to database lock.
• Excellent communication, interpersonal, and organizational skills.
• Ability to travel to study sites as required (up to 60% travel).
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Detail-oriented with strong problem-solving abilities.
• Must be able to work independently and as part of a larger team.

Benefits

• Competitive salary and performance-based incentives.
• Comprehensive health coverage, including medical, dental, and vision.
• Retirement fund contributions.
• Generous annual leave allowance.
• Continuous professional development opportunities.
• Travel expenses covered for site visits.
• Collaborative and supportive team environment.
• Opportunity to work on cutting-edge clinical research projects.