Clinical Research Associate (CRA) - Phase III Trials

Placements24; Centurion; Hybride; ZAR 600 000 - 900 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Medical aid

Retirement annuity

Hybrid work model

Professional development

Résumé du poste

Placements24 is seeking an experienced Clinical Research Associate to manage Phase III clinical trials. Based in Centurion with a hybrid work model, you will monitor sites, verify data integrity, and ensure regulatory compliance across studies in the pharmaceutical/biotech sector.

The role requires a life sciences or nursing degree and 3–5 years of CRA experience in Phase III trials. Strong communication and organizational skills are essential for success.

Qualifications

• Bachelor's degree in life sciences or nursing required.
• 3–5 years as CRA with Phase III experience.
• Thorough understanding of GCP, ICH, and regulatory requirements.
• Experience in site monitoring and data integrity.

Responsabilités

• Plan, execute and document site monitoring visits per protocol and SOPs.
• Verify data accuracy and completeness from source documents and CRFs.
• Ensure adherence to GCP, ICH, FDA regulations and local rules.
• Liaise between sponsor and trial sites to maintain strong relationships.
• Train site personnel on study protocols and regulatory requirements.
• Monitor progress, identify risks and implement CAPAs.
• Manage investigational product accountability and storage.
• Prepare monitoring reports and communicate findings to management.
• Facilitate site audits and regulatory inspections as required.

Connaissances

GCP/ICH compliance

Site monitoring

EDC systems

CTMS

Regulatory knowledge

Communication skills

Formation

Bachelor's degree in life sciences or nursing

Outils

CTMS

EDC

Description du poste

About the Role

Our client, a prominent player in the global pharmaceutical and biotechnology landscape, is seeking a dedicated and experienced Clinical Research Associate (CRA) to manage and oversee Phase III clinical trials. This role is crucial for ensuring the integrity, accuracy, and timeliness of clinical trial data. Based in Centurion, Gauteng , with a hybrid work arrangement, the CRA will be responsible for site monitoring, ensuring compliance with protocols, and maintaining regulatory standards. This is an excellent opportunity to contribute to groundbreaking medical research and advance patient care. The successful candidate will work within a supportive and professional environment, playing a key role in the successful execution of complex clinical studies. If you are passionate about clinical research and possess strong organizational skills, this role in Centurion is ideal for you.

Key Responsibilities

• Plan, execute, and document clinical site monitoring visits (initiation, routine, and close-out) according to study protocols and SOPs.
• Verify the accuracy, completeness, and compliance of clinical trial data by reviewing source documents and case report forms (CRFs).
• Ensure adherence to Good Clinical Practice (GCP) guidelines, FDA regulations, and local regulatory requirements.
• Serve as the primary liaison between the sponsor and clinical trial sites, fostering strong working relationships.
• Train site personnel on study protocols, investigational product handling, and regulatory requirements.
• Monitor site progress, identify potential risks, and implement corrective and preventive actions.
• Manage investigational product accountability and ensure proper storage and handling.
• Prepare monitoring reports and communicate findings and recommendations to the clinical trial manager and relevant stakeholders.
• Facilitate site audits and regulatory inspections as required.

Requirements

• A Bachelor's degree in a life science, nursing, or a related field; advanced degrees are a plus.
• Minimum of 3-5 years of experience as a Clinical Research Associate, with substantial experience in Phase III trials.
• Thorough understanding of GCP, ICH guidelines, and regulatory requirements for clinical trials.
• Proven experience in conducting site monitoring visits and ensuring data integrity.
• Excellent communication, interpersonal, and negotiation skills.
• Strong organizational and time management abilities, with a high degree of accuracy.
• Ability to work independently and as part of a team, demonstrating initiative and problem-solving skills.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Willingness to travel to clinical sites as needed (up to 40%).

Benefits

• Our client offers a competitive salary package, complemented by performance-based incentives.
• Comprehensive benefits include medical aid, life insurance, and a retirement annuity.
• Opportunities for professional development and continuing education are readily available.
• The hybrid work model allows for a flexible work-life balance.
• Join a dedicated team committed to advancing healthcare and enjoy a stimulating career in clinical research.
• Further benefits include ample annual leave and access to company wellness programs.