Clinical Research Associate - Phase III Trials

Placements24; Rustenburg; Hybrid; ZAR 650,000 - 900,000; Full time

Benefits offered by this job

Competitive salary package

Health, retirement, and life insurance

International travel opportunities

Flexible working arrangements

Rustenburg-based role

Job summary

Placements24 is seeking a seasoned Clinical Research Associate based near Rustenburg to monitor Phase III trials, ensure data integrity, and liaise between sponsors and study sites.

The role requires a life sciences or nursing background, 3+ years CRA experience, and strong knowledge of ICH-GCP and SA regulatory standards. EDC/eTMF experience is preferred, with opportunities for professional growth.

Qualifications

• Bachelor's degree in a life science, nursing, or related healthcare discipline.
• Minimum of 3 years of CRA or similar clinical trial monitoring experience.
• Strong knowledge of ICH-GCP and regulatory requirements for clinical trials in South Africa.
• Experience with Phase III trials is essential.
• Proficiency with clinical data management systems (EDC) and eTMF tooling.
• Excellent organizational and communication skills with high accuracy.

Responsibilities

• Monitor trial sites to ensure protocol and GCP compliance.
• Verify data accuracy via SDV and source document review.
• Conduct site initiation, interim, and close-out visits.
• Coordinate between investigators, site staff, and sponsor.
• Maintain regulatory documentation at sites and with sponsor.
• Oversee investigational product management and site procedures.

Skills

GCP/ICH compliance

Site monitoring

Data integrity

Regulatory knowledge

EDC systems

eTMF

Education

Bachelor's degree in life sciences or nursing

Tools

EDC systems

eTMF

Job description

About the Role

Our client is seeking a highly motivated and experienced Clinical Research Associate (CRA) to support critical Phase III clinical trials within the pharmaceutical sector. Based in the vicinity of Rustenburg , you will play a vital role in ensuring the safety and integrity of clinical trial data, acting as the primary link between the sponsor and participating study sites. This position demands meticulous attention to detail, strong organizational skills, and a deep understanding of clinical research methodologies and regulatory requirements. You will contribute to the advancement of new pharmaceutical treatments by effectively monitoring trial progress and site performance.

Key Responsibilities

• Monitor assigned clinical trial sites to ensure adherence to protocol, Good Clinical Practice (GCP) , and regulatory guidelines.
• Verify the accuracy, completeness, and consistency of clinical data through source data verification (SDV) and source document review.
• Conduct site initiation, interim, and close-out visits according to the Clinical Monitoring Plan.
• Manage communication between investigators, site staff, and the sponsor company, addressing protocol-related issues promptly.
• Ensure all required regulatory documentation is maintained and filed appropriately at study sites and with the sponsor.
• Oversee site compliance with study procedures and investigational product management.

Requirements

• Bachelor's degree in a life science, nursing, or related healthcare discipline.
• Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial monitoring role.
• Comprehensive knowledge of ICH-GCP guidelines and relevant regulatory requirements for clinical trials in South Africa.
• Experience with Phase III clinical trials is essential.
• Proficiency in using clinical data management systems (e.g., EDC systems) and electronic Trial Master Files (eTMF).
• Excellent organizational, time management, and communication skills, with a high level of accuracy.

Benefits

• Competitive salary package, reflecting your expertise and experience.
• Comprehensive health, retirement, and life insurance benefits.
• Opportunities for international travel and professional growth within a leading pharmaceutical organization.
• Flexible working arrangements supporting a positive work-life balance.
• Engage in groundbreaking research aimed at developing life-changing medicines, contributing from Rustenburg .