Clinical Research Associate (Pharmaceuticals)

Placements24; Bloemfontein; Hybrid; ZAR 420,000 - 560,000; Full time

Benefits offered by this job

Travel allowance

Medical insurance

Retirement fund

Professional development

Ethical environment

Job summary

Placements24 is seeking a dedicated Clinical Research Associate to support pharmaceutical clinical trials in the Welkom area. This hybrid role combines field-based activities with office responsibilities, focusing on site management, data integrity, and participant safety throughout the trial duration.

You will monitor sites per protocol and GCP, verify data via SDV, manage regulatory documents, and liaise between sites, the sponsor, and regulators.

Qualifications

• Bachelor's degree in a life science, nursing, or related field.
• Proven experience as a Clinical Research Associate or similar role.
• Strong knowledge of ICH-GCP guidelines and regulatory affairs.
• Experience with EDC and CTMS systems.
• Excellent communication and organizational skills.

Responsibilities

• Conduct site initiation, interim monitoring, and close-out visits per protocol and GCP.
• Verify data integrity through source data verification (SDV).
• Manage trial documentation including regulatory binders and accountability.
• Serve as main contact between sites, sponsor, and regulators.
• Identify and report adverse events per protocol.
• Train site staff on study procedures and data collection.

Skills

Organizational skills

Communication skills

Attention to detail

Multitasking

Problem solving

Team collaboration

Education

Bachelor’s degree in Life Science/Nursing or related field

Tools

EDC systems

CTMS

Job description

About the Role

Our client is seeking a dedicated Clinical Research Associate to support their vital pharmaceutical clinical trials in the Welkom area. This role involves ensuring the effective and efficient management of clinical trial sites, adhering strictly to protocols and regulatory standards. You will be instrumental in monitoring trial progress, ensuring data integrity, and safeguarding patient well-being throughout the trial duration. This hybrid role offers a mix of field-based activities and office-based responsibilities, providing a comprehensive experience in clinical research operations.

Key Responsibilities

• Conduct site initiation, interim monitoring, and close-out visits to ensure compliance with protocol, Good Clinical Practice (GCP) , and regulatory requirements.
• Verify the accuracy, completeness, and integrity of clinical data through source data verification (SDV).
• Manage trial-related documentation, including regulatory binders, essential documents, and investigational product accountability.
• Act as the primary point of contact between study sites, the sponsor, and regulatory authorities.
• Identify and report adverse events (AEs) and serious adverse events (SAEs) promptly according to protocol.
• Train site staff on study procedures, protocol requirements, and data collection methods.

Requirements

• Bachelor's degree in a life science, nursing, or related field.
• Proven experience as a Clinical Research Associate or in a similar clinical trial management role.
• Thorough understanding of clinical trial processes, ICH-GCP guidelines, and relevant regulatory affairs.
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Strong organizational skills, attention to detail, and ability to manage multiple tasks effectively.
• Excellent communication and interpersonal skills for effective site and team interactions.

Benefits

• Competitive annual salary and travel allowance.
• Comprehensive medical, disability, and life insurance coverage.
• Retirement fund participation.
• Generous opportunities for professional development and certifications.
• A stimulating and ethical work environment focused on advancing healthcare in Welkom .