Clinical Research Associate - Oncology Trials

Placements24; George; On-site; ZAR 600,000 - 800,000; Full time

Benefits offered by this job

Medical benefits

Dental & optical

Retirement plan

Travel allowances

Professional growth

Trial tech access

Job summary

Placements24 is seeking a meticulous Clinical Research Associate (CRA) with a strong oncology focus to manage crucial trials in and around George, Western Cape. The role centers on monitoring sites, ensuring protocol adherence, and safeguarding data integrity in line with ICH-GCP guidelines.

You will collaborate with investigators, site staff, and internal teams to ensure patient safety and accurate study results while supporting regulatory documentation and trial oversight.

Qualifications

• Bachelor's degree in life science, nursing, or related field; advanced degree preferred.
• Minimum of 5 years as a CRA with oncology focus.
• Thorough understanding of ICH-GCP and regulatory requirements.
• Proven experience monitoring clinical trial sites and ensuring data integrity.
• Excellent verbal and written communication skills.
• Strong organizational skills and meticulous attention to detail.
• Proficiency in CTMS and EDC systems.
• Ability to travel to clinical trial sites as required.
• Ability to work independently and in a team.
• Proactive problem-solving and risk mitigation in clinical research.

Responsibilities

• Conduct site initiation, interim monitoring, and close-out visits to assess protocol compliance and patient safety.
• Ensure activities follow study protocol, SOPs, and regulatory requirements (ICH-GCP).
• Verify accurate data collection and reporting in CRFs and EDC systems.
• Manage data discrepancies and query resolution with site personnel.
• Monitor drug accountability, storage, and dispensing at investigational sites.
• Build and maintain relationships with principal investigators and study sponsors.
• Prepare and submit regulatory documents and maintain site files.
• Identify, report, and track AEs and SAEs per protocol and guidelines.
• Contribute to study protocol development and trial plans.
• Oversee site audits and regulatory inspections.

Skills

Site monitoring

Data integrity

CTMS proficiency

EDC proficiency

Travel readiness

Communication skills

Organizational skills

Education

Bachelor’s degree in life science / nursing or related field

Advanced degree preferred

Tools

CTMS

EDC

Job description

About the Role

Our client, a prominent biopharmaceutical company, is seeking a meticulous and dedicated Clinical Research Associate (CRA) to manage and oversee critical oncology clinical trials based in or near George . This role is essential for ensuring the integrity and quality of data collected during these vital studies. The CRA will be responsible for monitoring clinical trial sites, ensuring adherence to protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. This position requires a strong understanding of oncology, clinical trial operations, and data management. The successful candidate will play a crucial role in bringing potentially life-saving cancer treatments to patients by meticulously managing the execution of clinical trials. You will work closely with investigators, site staff, and internal project teams to guarantee the safety of participants and the accuracy of study results. The role demands exceptional organizational skills, attention to detail, and the ability to foster strong working relationships with all stakeholders involved in the trial process.

Key Responsibilities

• Conduct site initiation, interim monitoring, and close-out visits for clinical trial sites to assess protocol compliance, data accuracy, and patient safety.
• Ensure all clinical trial activities are conducted in accordance with the study protocol, Standard Operating Procedures (SOPs), and applicable regulatory requirements (e.g., ICH-GCP).
• Verify the accurate and timely collection, documentation, and reporting of study data in Case Report Forms (CRFs) and electronic data capture (EDC) systems.
• Manage and resolve data discrepancies and query resolution with site personnel.
• Monitor drug accountability, storage, and dispensing at investigational sites.
• Build and maintain strong working relationships with principal investigators, site staff, and study sponsors.
• Prepare and submit essential regulatory documents and maintain site files.
• Identify, report, and track adverse events (AEs) and serious adverse events (SAEs) according to protocol and regulatory guidelines.
• Contribute to the development of study protocols, clinical trial plans, and other study-related documents.
• Oversee site audits and regulatory inspections as needed.

Requirements

• Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
• Minimum of 5 years of experience as a Clinical Research Associate (CRA) with a significant focus on oncology clinical trials.
• Thorough understanding of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
• Proven experience in monitoring clinical trial sites and managing data integrity.
• Excellent verbal and written communication skills, with the ability to clearly articulate complex information.
• Strong organizational skills and meticulous attention to detail.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to clinical trial sites as required.
• Demonstrated ability to work independently and collaboratively within a team environment.
• A proactive approach to problem-solving and risk mitigation in clinical research.

Benefits

• An attractive annual salary package of ZAR.
• Comprehensive medical, dental, and optical benefits.
• Retirement savings plan with company contribution.
• Opportunities for professional growth and training in clinical research methodologies.
• Travel allowances and per diem for site visits.
• A dynamic and supportive work environment within the growing field of oncology research.
• Access to innovative clinical trial technologies and resources.
• The opportunity to contribute to the advancement of cancer therapies in George and surrounding areas.