Clinical Research Associate (CRA)

Placements24; Bloemfontein; Hybrid; ZAR 420,000 - 650,000; Full time

Benefits offered by this job

Health benefits

Paid time off

Professional development

Hybrid work model

Job summary

Placements24 is seeking a dedicated Clinical Research Associate to join our clinical operations team in the Bloemfontein region, with hybrid work flexibility. You will monitor trial sites to ensure studies are conducted, recorded, and reported in line with protocol, SOPs, and GCP guidelines, ensuring patient safety and data integrity.

The ideal candidate has a life sciences degree, at least 3 years of CRA or monitoring experience, and strong communication skills.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related discipline.
• Minimum of 3 years of experience as a Clinical Research Associate or equivalent monitoring role.
• Thorough understanding of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements.

Responsibilities

• Conduct site initiation, interim monitoring, and close-out visits in accordance with study requirements and GCP.
• Verify the accuracy and completeness of source data and ensure its consistency with the Case Report Forms (CRFs).
• Ensure compliance with the study protocol, regulatory requirements, and SOPs at assigned clinical sites.
• Manage communication between the investigative sites and the clinical trial team.
• Oversee site compliance, review regulatory binders, and ensure proper investigational product accountability.
• Identify and elevate any site-level issues or protocol deviations to the project manager.

Skills

GCP

ICH Guidelines

Site Monitoring

Regulatory Knowledge

Education

Bachelor's degree in Life Sciences or related field

Job description

About the Role

Our client is actively seeking a dedicated and experienced Clinical Research Associate (CRA) to join their clinical operations team, supporting studies primarily in the Bloemfontein area, with potential for hybrid work flexibility. As a CRA, you will be responsible for monitoring clinical trial sites to ensure the study is conducted, recorded, and reported in accordance with the study protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP) guidelines. Your role is vital in maintaining data integrity and patient safety throughout the clinical trial process, contributing to the successful development of new pharmaceutical treatments.

Key Responsibilities

• Conduct site initiation, interim monitoring, and close-out visits in accordance with study requirements and GCP.
• Verify the accuracy and completeness of source data and ensure its consistency with the Case Report Forms (CRFs).
• Ensure compliance with the study protocol, regulatory requirements, and SOPs at assigned clinical sites.
• Manage communication between the investigative sites and the clinical trial team.
• Oversee site compliance, review regulatory binders, and ensure proper investigational product accountability.
• Identify and elevate any site-level issues or protocol deviations to the project manager.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline.
• Minimum of 3 years of experience as a Clinical Research Associate or equivalent monitoring role.
• Thorough understanding of Good Clinical Practice (GCP) , ICH guidelines, and local regulatory requirements.
• Experience with clinical trial monitoring, site management, and data verification.
• Excellent organizational skills, attention to detail, and strong written and verbal communication abilities.
• Ability to travel to clinical sites as required, while benefiting from hybrid work flexibility.

Benefits

• Competitive annual salary with performance-based incentives.
• Comprehensive health and wellness benefits package.
• Paid time off and company-observed holidays.
• Opportunities for professional development and training in clinical research.
• Flexible hybrid work model supporting work-life balance in the Bloemfontein region.