Senior Pharmaceutical Clinical Research Associate (CRA)

Placements24; Soweto; Hybride; ZAR 600 000 - 800 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Travel allowances

Health insurance

Professional development

Collaborative work environment

Résumé du poste

Placements24 is seeking a Senior Pharmaceutical Clinical Research Associate to support trials in Soweto, Gauteng. The role focuses on site selection, initiation, monitoring, and close-out visits, ensuring data integrity and participant safety.

You will monitor adherence to protocols and regulatory requirements, train site staff, manage trial supplies, and collaborate with cross-functional teams to drive quality and regulatory compliance across multiple sites in the Soweto area.

Qualifications

• Bachelor's degree in life science, nursing, pharmacy or related field.
• 4–6 years as a Clinical Research Associate with ICH-GCP knowledge.
• Experience monitoring Phase II/III clinical trials and site management.

Responsabilités

• Conduct site selection, initiation, monitoring and close-out visits per GCP and protocol.
• Ensure data quality and integrity across study sites.
• Verify adherence to protocol, plan and regulatory requirements.
• Maintain relationships with investigative sites and staff.
• Train and mentor site personnel on study procedures and regulatory requirements.
• Identify and address site risks and issues.
• Prepare monitoring visit reports and track action items.
• Manage investigational product accountability and supplies.
• Collaborate with project managers, data managers and study physicians.
• Stay updated on clinical research best practices and regulatory updates.

Connaissances

Site monitoring

GCP/ICH knowledge

CTMS experience

EDC experience

Travel readiness

Formation

Bachelor's degree in life sciences

Outils

CTMS

EDC systems

Description du poste

About the Role Our client, a leading contract research organization (CRO) dedicated to advancing global health, is actively recruiting a Senior Pharmaceutical Clinical Research Associate (CRA) to support trials within the Soweto, Gauteng area. This critical role involves ensuring the efficient and compliant execution of clinical trials, safeguarding the integrity of data, and protecting the rights and well-being of study participants. You will be responsible for site selection, initiation, monitoring, and close-out visits, ensuring adherence to study protocols, SOPs, and regulatory requirements (GCP, ICH). The ideal candidate will possess extensive experience in clinical trial monitoring, strong organizational skills, and a deep understanding of pharmaceutical development. This position offers the chance to contribute to life‑saving research at various clinical sites in and around Soweto, Gauteng .

Key Responsibilities

• Conduct site selection, initiation, interim monitoring, and close‑out visits in accordance with GCP and study‑specific requirements.
• Ensure the quality, integrity, and accuracy of data recorded by study sites.
• Verify that study conduct adheres to the approved protocol, study plan, and applicable regulations.
• Build and maintain positive relationships with investigative sites and study staff.
• Train and mentor site personnel on study protocols, procedures, and regulatory requirements.
• Identify, document, and expand potential risks and issues at clinical trial sites.
• Prepare and present monitoring visit reports and follow up on action items.
• Manage clinical trial supplies and ensure compliance with investigational product accountability.
• Collaborate with internal teams, including project managers, data managers, and study physicians.
• Stay current with clinical research best practices and regulatory updates.

Requirements

• Bachelor's degree in a life science, nursing, pharmacy, or a related field.
• Minimum of 4-6 years of experience as a Clinical Research Associate, with a strong understanding of ICH-GCP guidelines and clinical trial processes.
• Proven experience in monitoring Phase II and/or Phase III pharmaceutical clinical trials.
• Demonstrated ability to manage multiple study sites effectively and independently.
• Excellent organizational, time management, and problem‑solving skills.
• Strong written and verbal communication skills, with the ability to communicate complex information clearly.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel extensively within the assigned territory (approx. 60-70%).
• A proactive approach to identifying and resolving site issues.
• Commitment to maintaining data integrity and patient safety.

Benefits

• Competitive salary and travel allowances.
• Performance‑based incentives and bonuses.
• Comprehensive health insurance and retirement benefits.
• Generous paid time off and holiday schedule.
• Opportunities for professional growth and development, including specialized training.
• A dynamic and collaborative work environment supporting cutting‑edge research in Soweto, Gauteng .