Senior Clinical Research Associate (CRA) - Oncology

Placements24; Pretoria; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Health insurance

Retirement contributions

Paid time off

Performance-based incentives

Professional development

Job summary

Our client, a renowned global pharmaceutical company, is seeking a Senior Clinical Research Associate to join the Pretoria, Gauteng team. The role involves monitoring clinical trial sites, ensuring protocol adherence, GCP compliance, and data integrity across oncology studies.

You will build relationships with investigators, manage site activities, and contribute to study documents while traveling to trial sites as required. This position emphasizes expertise in SDV and regulatory oversight.

Qualifications

• Bachelor's degree in a life science, nursing, or related field.
• Minimum of 5 years of direct experience as a Clinical Research Associate, with a significant portion focused on oncology trials.
• In‑depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
• Proven experience in site monitoring, SDV, and ensuring data integrity.
• Excellent understanding of oncology clinical trial processes and therapeutic areas.

Responsibilities

• Conduct pre-study, initiation, routine monitoring, and close‑out visits to clinical trial sites according to protocol, GCP, and regulatory requirements.
• Verify the accuracy, completeness, and integrity of clinical trial data through source data verification (SDV).
• Ensure investigational product accountability and proper handling at the site.
• Manage site‑level activities, build relationships with investigators and site staff, and provide ongoing training and support.
• Identify, document, and report site deviations and ensure timely implementation of corrective actions.
• Oversee regulatory compliance at the site level, ensuring all documentation is complete and current.
• Communicate with internal project teams (project managers, data managers, medical monitors).
• Contribute to development of study documents (protocols, CRFs, monitoring plans).
• Participate in Investigator Meetings and train new CRAs as needed.

Skills

Oncology trials knowledge

GCP/ICH knowledge

Communication skills

Travel flexibility

Site monitoring

Education

Bachelor's degree in life science or related field

Tools

CTMS

EDC systems

Job description

About the Role

Our client, a renowned global pharmaceutical company with a strong focus on oncology research, is looking for an experienced Senior Clinical Research Associate (CRA) to join their expanding team in Pretoria, Gauteng. This critical role involves overseeing and managing clinical trial sites to ensure the efficient and accurate execution of oncology studies. The Senior CRA will be responsible for monitoring study progress, ensuring adherence to protocols, regulatory requirements, and Good Clinical Practices (GCP). You will play a vital part in bringing life‑saving cancer treatments to patients by ensuring the integrity and quality of clinical trial data. This is an exciting opportunity to work on cutting‑edge oncology trials and collaborate with leading investigators and healthcare professionals. We seek a highly organized, detail‑oriented professional with a passion for clinical research and improving patient outcomes. The Pretoria, Gauteng location offers a central hub for professional engagement.

Key Responsibilities

• Conduct pre-study, initiation, routine monitoring, and close‑out visits to clinical trial sites according to protocol, GCP, and regulatory requirements.
• Verify the accuracy, completeness, and integrity of clinical trial data through source data verification (SDV).
• Ensure investigational product accountability and proper handling at the site.
• Manage site‑level activities, build strong relationships with investigators and site staff, and provide ongoing training and support.
• Identify, document, and report site deviations and ensure timely implementation of corrective actions.
• Oversee regulatory compliance at the site level, ensuring all necessary documentation is complete and current.
• Communicate effectively with internal project teams, including project managers, data managers, and medical monitors.
• Contribute to the development and finalization of study‑related documents, such as protocols, case report forms (CRFs), and monitoring plans.
• Participate in Investigator Meetings and provide training to new CRAs as needed.

Requirements

• Bachelor's degree in a life science, nursing, or related field.
• Minimum of 5 years of direct experience as a Clinical Research Associate, with a significant portion focused on oncology trials.
• In‑depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements for clinical trials.
• Proven experience in site monitoring, SDV, and ensuring data integrity.
• Excellent understanding of oncology clinical trial processes and therapeutic areas.
• Strong communication, interpersonal, and organizational skills.
• Ability to travel frequently to clinical trial sites as required.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Demonstrated ability to work independently and manage workload effectively.

Benefits

Our client offers a competitive salary, performance‑based incentives, and a comprehensive benefits package including health insurance, retirement contributions, and generous paid time off. We invest in our employees' professional development, offering opportunities for specialized training and career advancement. This role provides the chance to make a real difference in the fight against cancer. Based in Pretoria, Gauteng, this position is ideal for professionals seeking a challenging and rewarding career in pharmaceutical research. Join a company that values your expertise and dedication to improving patient lives through innovative oncology treatments.