Clinical Research Associate - Pharmaceutical Development

Placements24; George; On-site; ZAR 700,000 - 1,000,000; Full time

Benefits offered by this job

Competitive salary and bonuses

Company car or travel allowance

Medical aid and retirement fund

Job summary

Placements24 in George, Western Cape seeks a dedicated Clinical Research Associate (CRA) to oversee and manage clinical trials, ensuring data integrity, patient safety, and regulatory compliance. The role requires frequent travel to study sites within the Western Cape region.

You will monitor sites, verify SDV data, manage recruitment and retention, and support site staff with study procedures while maintaining strong sponsor relationships.

Qualifications

• Bachelor's degree in life science, nursing, or related discipline.
• Minimum of 3 years of experience as a Clinical Research Associate, with monitoring experience.
• In-depth knowledge of ICH-GCP guidelines, regulatory requirements (e.g., SAHPRA), and trial processes.
• Experience with various therapeutic areas is preferred.
• Excellent understanding of trial documentation and data management systems.
• Strong organizational, time management, and multitasking abilities.
• Exceptional written and verbal communication skills.
• Proficiency in CTMS and EDC systems.
• Willingness to travel within Western Cape and beyond.
• Must be based in or commute to George.

Responsibilities

• Monitor trial activities at investigative sites to ensure protocol, GCP, and regulatory compliance.
• Verify accuracy and consistency of trial data via source data verification.
• Manage site recruitment, enrollment, and retention to ensure timely study completion.
• Conduct pre-study, initiation, interim, and close-out monitoring visits.
• Train and support site staff on study procedures and regulatory requirements.
• Build and maintain relationships with investigators, site staff, and sponsors.
• Prepare and submit monitoring reports and study documentation in a timely manner.
• Ensure investigational product is accounted for and handled per protocol.
• Assist in resolving site-specific issues and escalate problems as needed.

Skills

GCP knowledge

Data management

Communication skills

Education

Bachelor's degree in life sciences or nursing

Tools

CTMS

EDC systems

Job description

About the Role

Our client, a dynamic and research-driven pharmaceutical company, is seeking a dedicated Clinical Research Associate (CRA) to join their expanding team in George, Western Cape . This critical role involves overseeing and managing clinical trials to ensure data integrity, patient safety, and compliance with all applicable regulations and protocols. You will be instrumental in the successful execution of studies, working closely with investigative sites, study sponsors, and regulatory authorities. This is an excellent opportunity for a skilled CRA to contribute to groundbreaking medical advancements within a reputable organization. The position requires significant travel to study sites within the region.

Key Responsibilities

• Monitor clinical trial activities at investigative sites to ensure adherence to protocol, GCP guidelines, and regulatory requirements.
• Verify accuracy, completeness, and consistency of clinical data through source document review and source data verification (SDV).
• Manage site recruitment, enrollment, and retention activities, ensuring timely completion of studies.
• Conduct pre-study, initiation, interim, and close-out monitoring visits.
• Train and support site staff on study procedures, regulatory requirements, and data collection.
• Build and maintain strong working relationships with investigators, site staff, and study sponsors.
• Prepare and submit monitoring reports and study-related documentation in a timely manner.
• Ensure all investigational product is accounted for and handled according to protocol.
• Assist in the resolution of site-specific issues and elevate problems as necessary.

Requirements

• Bachelor's degree in a life science, nursing, or related discipline.
• Minimum of 3 years of experience as a Clinical Research Associate, with a proven track record in monitoring clinical trials.
• In-depth knowledge of ICH-GCP guidelines, regulatory requirements (e.g., SAHPRA), and clinical trial processes.
• Experience with various therapeutic areas is preferred.
• Excellent understanding of clinical trial documentation and data management systems.
• Strong organizational, time management, and multitasking abilities.
• Exceptional written and verbal communication skills, with the ability to present complex information clearly.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Willingness to travel extensively within the Western Cape region and occasionally beyond.
• Must be based in or able to commute reliably to George .

Benefits

• Competitive salary package, including performance-based bonuses.
• Company car or travel allowance for site visits.
• Comprehensive medical aid and retirement fund contributions.
• Extensive training and professional development opportunities.
• A supportive team environment focused on collaboration and scientific advancement.
• Opportunity to work on diverse and impactful clinical research projects.