Clinical Research Associate (CRA) - Pharmaceutical Trials

Placements24; Rustenburg; Hybrid; ZAR 550,000 - 850,000; Full time

Benefits offered by this job

Health insurance

Retirement fund

Travel allowances

Training programs

Performance-based incentives

Job summary

Placements24 seeks a meticulous Clinical Research Associate (CRA) to join our client’s expanding team in Rustenburg, North West. The CRA will monitor trial sites, ensure data integrity, and uphold patient safety throughout the trial lifecycle.

The role requires 3–5 years of CRA experience, strong knowledge of GCP/ICH guidelines, and proficiency with CTMS/EDC systems. Travel to sites will be required as needed.

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• GCP/ICH guidelines knowledge essential.
• Experience monitoring clinical trials (CRA) in pharma/CRO preferred.
• Strong organizational and communication skills required.
• Willingness to travel to trial sites.

Responsibilities

• Monitor clinical trial sites for protocol and SOP compliance.
• Conduct site initiation, monitoring, and closure visits.
• Verify data via source data verification (SDV).
• Resolve data queries and discrepancies promptly.
• Oversee patient safety and AE/SAE reporting.

Skills

GCP/ICH knowledge

Site monitoring

Data integrity

Communication

Problem solving

Education

Bachelor's degree in Life Sciences or related field

Master's degree (advantage)

Tools

CTMS

EDC systems

Job description

About the Role

Our client, a dynamic and growing pharmaceutical company, is seeking a meticulous and proactive Clinical Research Associate (CRA) to join their expanding team based in Rustenburg, North West . This role is integral to the successful execution of clinical trials, ensuring adherence to protocols, regulatory guidelines, and data integrity. The CRA will be responsible for monitoring clinical trial sites, managing data collection, and ensuring patient safety throughout the trial lifecycle. This position offers an excellent opportunity for individuals passionate about advancing medical treatments and contributing to pharmaceutical innovation within the North West region. The Rustenburg area provides a unique setting for this vital role in healthcare research.

Key Responsibilities

• Monitor assigned clinical trial sites to ensure compliance with study protocols, Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP) guidelines.
• Conduct site initiation, interim monitoring visits, and site closure visits.
• Verify the accuracy, completeness, and consistency of clinical trial data through source data verification (SDV).
• Ensure timely resolution of data queries and discrepancies.
• Oversee patient safety and reporting of adverse events (AEs) and serious adverse events (SAEs).
• Act as a liaison between the sponsor, investigative sites, and ethics committees.
• Train and support site staff on protocol requirements and study procedures.
• Manage study supplies and investigational product accountability at the sites.
• Prepare and submit monitoring visit reports in a timely manner.
• Contribute to the development of clinical trial documentation, including protocols and case report forms (CRFs).

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• A Master's degree is a plus.
• Minimum of 3-5 years of direct experience as a Clinical Research Associate (CRA) in the pharmaceutical industry or a Contract Research Organization (CRO).
• Thorough understanding of GCP, ICH guidelines, and relevant regulatory requirements.
• Proven experience in monitoring clinical trials across various therapeutic areas.
• Excellent understanding of clinical trial processes and documentation.
• Strong organizational, time management, and problem-solving skills.
• Excellent interpersonal and communication skills, with the ability to build rapport with site personnel.
• Proficiency in clinical trial management software (CTMS) and electronic data capture (EDC) systems.
• Willingness to travel to assigned clinical trial sites as required.
• Ability to work independently and manage multiple priorities effectively.

Benefits

Our client offers a competitive compensation package, including a comprehensive health insurance plan, retirement fund contributions, and performance-based incentives. This role is based in Rustenburg , providing a stable work environment and opportunities for professional growth. Additional benefits include travel allowances, continuous training programs, and the chance to be part of groundbreaking medical research. Join a team that is dedicated to improving patient lives through innovative pharmaceutical development.