Clinical Research Associate (CRA)

Placements24; Kempton Park; On-site; ZAR 520,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Medical and retirement benefits

Paid time off and sick leave

Travel expenses reimbursed for sitevis

Professional development opportunities

Job summary

Placements24 is seeking a dedicated Clinical Research Associate (CRA) to monitor sites across the region in South Africa, ensuring data accuracy and participant safety in line with ICH-GCP guidelines. The role involves travel to clinical sites, coordination with investigators, and management of trial documentation.

The ideal candidate has a life sciences or nursing background with at least 3 years of CRA experience and hands-on experience with EDC and CTMS systems.

Qualifications

• Bachelor's degree in life sciences, nursing or related field.
• Minimum of 3 years of experience as a Clinical Research Associate or similar role.
• In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.

Responsibilities

• Conduct site initiation, monitoring, and close-out visits for clinical trial sites.
• Verify the accuracy, completeness, and integrity of clinical data collected at study sites.
• Ensure compliance with the clinical trial protocol, ICH-GCP guidelines, and all applicable regulations.
• Manage communication between sponsor and clinical trial sites, addressing queries or issues promptly.
• Train site personnel on study procedures and documentation requirements.
• Maintain accurate site documentation and regulatory files.

Skills

Organizational skills

Communication

Interpersonal skills

Travel readiness

Education

Bachelor's degree in life sciences / nursing 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 growing team in Tembisa. This role is crucial for ensuring the successful execution of clinical trials in compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements. You will be responsible for monitoring clinical trial sites, ensuring data accuracy, and managing participant safety throughout the trial process. This position offers the opportunity to make a significant impact on bringing new pharmaceutical products to market and improving healthcare outcomes, working closely with investigators and study teams at various clinical sites across the region.

Key Responsibilities

• Conduct site initiation, monitoring, and close-out visits for clinical trial sites.
• Verify the accuracy, completeness, and integrity of clinical data collected at study sites.
• Ensure compliance with the clinical trial protocol, ICH-GCP guidelines , and all applicable regulations.
• Manage communication between the sponsor and clinical trial sites, addressing any queries or issues promptly.
• Train site personnel on study-specific procedures and documentation requirements.
• Maintain accurate and up-to-date site documentation and regulatory files.

Requirements

• Bachelor's degree in a life science, nursing, or related field.
• Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial monitoring role.
• In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Excellent organizational, communication, and interpersonal skills.
• Ability to travel to clinical sites as required for monitoring activities in the Tembisa area and beyond.

Benefits

• Competitive annual salary and potential for performance bonuses.
• Comprehensive medical and retirement benefits package.
• Paid time off and sick leave.
• Travel expenses reimbursed for site visits.
• Professional development opportunities and ongoing training in clinical research.