Clinical Research Associate (CRA) - Phase III Trials

Placements24; Kempton Park; On-site; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Travel allowance

Health, wellness & life insurance

Retirement fund contribution

Career advancement

Ongoing training & professional dev.

Per diem for overnight travel

Company mobile phone and laptop

Job summary

Placements24 is seeking a dedicated Clinical Research Associate (CRA) to join their expanding clinical operations team in South Africa. This field-based role monitors trial sites, ensures data integrity, and verifies regulatory compliance for Phase III studies.

The successful candidate will travel up to 70% across Tembisa, Gauteng and surrounding areas, hold a Life Sciences degree, at least 3 years of CRA experience, and be proficient with GCP/ICH and EDC systems.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
• Minimum of 3 years of direct CRA experience with significant exposure to Phase III trials.
• In-depth knowledge of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
• Proven experience in site monitoring, data verification, and query resolution.

Responsibilities

• Conduct on-site visits to investigational sites to monitor progress, data accuracy, and compliance with protocols, SOPs, and GCP.
• Verify source documentation against case report forms (CRFs) to ensure data integrity.
• Train site staff on study procedures, regulatory requirements, and data collection processes.
• Manage and resolve data queries in a timely and efficient manner.
• Ensure all study-related documentation is maintained accurately and securely at the site and in the trial master file.
• Identify, report, and escalate any deviations, potential risks, or adverse events to the clinical trial manager.
• Build and maintain strong working relationships with investigators and site personnel.
• Participate in investigator meetings and provide updates on site performance.
• Contribute to the development and review of study protocols and other essential documents.

Skills

Site monitoring

Data verification

Travel readiness

GCP/ICH knowledge

Communication skills

Education

Bachelor's degree in Life Sciences/Nursing/Pharmacy

Tools

EDC systems

Job description

Our client, a prominent player in the pharmaceutical industry, is actively seeking a dedicated and detail-oriented Clinical Research Associate (CRA) to join their expanding clinical operations team. This vital role involves ensuring the integrity and quality of data collected during Phase III clinical trials. You will be responsible for monitoring investigational sites, verifying compliance with study protocols and regulatory guidelines, and ensuring the safety of study participants. This position is field-based, requiring extensive travel to clinical sites within and around Tembisa, Gauteng, and surrounding areas. The successful candidate will be a key contributor to the successful execution of critical drug development programs, contributing directly to bringing new therapies to patients. We pride ourselves on a rigorous approach to clinical research and a commitment to ethical conduct.

Key Responsibilities

• Conduct on-site visits to investigational sites to monitor study progress, data accuracy, and compliance with protocols, SOPs, and Good Clinical Practice (GCP).
• Verify source documentation against case report forms (CRFs) to ensure data integrity and completeness.
• Train site staff on study-specific procedures, regulatory requirements, and data collection processes.
• Manage and resolve data queries in a timely and efficient manner.
• Ensure all study-related documentation is maintained accurately and securely at the site and in the trial master file.
• Identify, report, and escalation any deviations, potential risks, or adverse events to the clinical trial manager.
• Build and maintain strong working relationships with investigators and site personnel.
• Participate in investigator meetings and provide updates on site performance.
• Contribute to the development and review of study protocols and other essential documents.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
• Minimum of 3 years of direct experience as a Clinical Research Associate, with significant exposure to Phase III trials.
• In-depth knowledge of Good Clinical Practice (GCP), ICH guidelines, and relevant regulatory requirements.
• Proven experience in site monitoring, data verification, and query resolution.
• Excellent understanding of clinical trial processes and documentation.
• Strong analytical and problem-solving skills, with exceptional attention to detail.
• Proficiency in Electronic Data Capture (EDC) systems and other clinical trial management software.
• Excellent interpersonal and communication skills, both written and verbal.
• Willingness and ability to travel frequently to clinical sites, up to 70% of the time.
• Must possess a valid driver's license and have access to a reliable vehicle.

Benefits

• Competitive annual salary based on experience and qualifications.
• Travel allowance and reimbursement for all business-related expenses.
• Comprehensive health, wellness, and life insurance coverage.
• Retirement fund contribution.
• Opportunities for career advancement within a growing organization.
• Ongoing training and professional development in clinical research.
• Per diem for overnight travel.
• Company-provided mobile phone and laptop.