Clinical Research Associate (CRA) - Remote

Placements24; Centurion; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Professional development

Remote team culture

Job summary

Placements24 is seeking a dedicated and experienced Clinical Research Associate (CRA) to join their globally distributed clinical operations team. This fully remote position enables you to contribute from anywhere within South Africa.

You will oversee site visits, ensure data integrity, and support study protocols in alignment with GCP standards. Ideal candidates have a minimum of 3 years as a CRA and strong knowledge of GCP/ICH guidelines, regulatory requirements, and experience with EDC and

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field.
• Minimum of 3 years of experience as a Clinical Research Associate.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
• Experience with EDC systems and CTMS.

Responsibilities

• Conduct pre-study, initiation, interim monitoring, and close-out visits for clinical trial sites.
• Verify the accuracy, completeness, and integrity of clinical data through source data verification (SDV).
• Ensure investigator sites comply with study protocols, GCP, FDA regulations, and other applicable guidelines.
• Train and support site staff on study-related procedures and regulatory requirements.
• Communicate effectively with investigators, site staff, project teams, and regulatory authorities.
• Manage site issues and escalation challenges promptly to the clinical project manager.

Skills

GCP knowledge

ICH guidelines

Data verification (SDV)

Remote workload management

Regulatory compliance

Education

Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field

Tools

EDC systems

CTMS

Job description

About the Role

Our client is seeking a dedicated and experienced Clinical Research Associate (CRA) to join their globally distributed clinical operations team. This is a fully remote position, allowing you to contribute from anywhere within South Africa. You will be instrumental in ensuring the successful execution of clinical trials, performing site visits, and verifying data integrity according to Good Clinical Practice (GCP) guidelines and study protocols. This role is crucial for maintaining the quality and compliance of our client's research studies, supporting the development of life-changing pharmaceuticals. Embrace a flexible work environment while making a vital contribution to groundbreaking medical research.

Key Responsibilities

• Conduct pre-study, initiation, interim monitoring, and close-out visits for clinical trial sites.
• Verify the accuracy, completeness, and integrity of clinical data through source document verification (SDV).
• Ensure investigator sites comply with study protocols, GCP, FDA regulations, and other applicable guidelines.
• Train and support site staff on study-related procedures and regulatory requirements.
• Communicate effectively with investigators, site staff, project teams, and regulatory authorities.
• Manage site issues and escalation challenges promptly to the clinical project manager.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• Minimum of 3 years of experience as a Clinical Research Associate .
• In-depth knowledge of GCP, ICH guidelines , and regulatory requirements for clinical trials.
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Excellent organizational, time management, and problem-solving skills.
• Ability to work independently and manage a remote workload effectively.

Benefits

• Competitive salary and performance-based incentives.
• Comprehensive health insurance and wellness programs.
• Opportunities for professional development and certifications.
• Significant contribution to cutting-edge clinical research.
• A supportive and collaborative remote team culture, promoting work-life balance.