Clinical Research Associate (CRA) - Pharmaceutical Trials

Placements24; Durban; On-site; ZAR 700,000 - 900,000; Full time

Benefits offered by this job

Competitive remuneration

Medical and retirement benefits

Career development

Job summary

Placements24 is seeking an experienced Clinical Research Associate (CRA) to join a global pharmaceutical organization in Durban, KwaZulu-Natal. This field-based role requires regular travel to study sites, ensuring trials adhere to GCP, ICH guidelines, and regulatory standards while safeguarding patient safety and data integrity.

You will monitor sites, verify data, train staff, and manage investigational products, with opportunities for professional development in a collaborative environment.

Qualifications

• Bachelor's degree in a life science, nursing, or related healthcare discipline.
• Minimum of 3-5 years of experience as a Clinical Research Associate, preferably within a pharmaceutical or CRO.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.

Responsibilities

• Perform site selection, initiation, monitoring, and close-out visits for clinical trial sites.
• Ensure compliance with study protocols, SOPs, GCP, and regulatory requirements.
• Verify the accuracy, completeness, and consistency of clinical data by reviewing source documents and eCRFs.
• Monitor patient safety and report adverse events (AEs) and serious adverse events (SAEs).
• Build and maintain relationships with investigators, site staff, and other stakeholders.
• Provide training and support to site personnel on study procedures.
• Manage study supplies and investigational product accountability at sites.
• Prepare monitoring reports and study documentation.

Skills

GCP knowledge

Site monitoring

Communication

CTMS usage

Education

Bachelor's degree in life science/nursing

Tools

CTMS

EDC systems

Job description

About the Role

Our client, a prominent global pharmaceutical organization, is seeking an experienced and dedicated Clinical Research Associate (CRA) to join their expanding clinical operations team in Durban, KwaZulu-Natal . This role is pivotal in ensuring the successful execution of clinical trials according to Good Clinical Practice (GCP) guidelines and regulatory standards. You will be responsible for monitoring clinical trial sites, ensuring patient safety, data integrity, and protocol compliance. This is a field-based position requiring regular travel to study sites within the region. The ideal candidate will possess strong knowledge of clinical trial processes, excellent interpersonal skills, and a commitment to advancing medical research. Become part of a team that is at the forefront of developing life-saving therapies.

Key Responsibilities

• Perform site selection, initiation, monitoring, and close-out visits for clinical trial sites.
• Ensure compliance with study protocols, Standard Operating Procedures (SOPs), GCP, and applicable regulatory requirements.
• Verify the accuracy, completeness, and consistency of clinical data by reviewing source documents and electronic case report forms (eCRFs).
• Monitor patient safety and report adverse events (AEs) and serious adverse events (SAEs) promptly.
• Build and maintain strong relationships with investigators, site staff, and other stakeholders.
• Provide training and support to site personnel on study-specific procedures and requirements.
• Manage study supplies and investigational product accountability at clinical sites.
• Prepare monitoring reports, follow-up letters, and other essential study documentation.

Requirements

• Bachelor's degree in a life science, nursing, or related healthcare discipline.
• Minimum of 3-5 years of experience as a Clinical Research Associate, preferably within a pharmaceutical or contract research organization (CRO).
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements for clinical trials.
• Proven experience in conducting site monitoring visits and assessing data integrity.
• Excellent communication, interpersonal, and organizational skills.
• Ability to travel regularly within the designated region (approximately 50-70% travel).
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Strong problem-solving abilities and a proactive approach to identifying and resolving site issues.

Benefits

• Our client offers a competitive remuneration package, including a generous base salary and travel allowances.
• Comprehensive medical and retirement benefits are provided, along with opportunities for continuous professional development and career advancement.
• You will be joining a supportive and collaborative environment dedicated to making a significant impact on global health.