Phase III CRA - Data Integrity & Site Monitoring

Placements24

Rustenburg

Hybrid

ZAR 650,000 - 900,000

Full time

3 days ago
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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

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.

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