Clinical Research Associate (CRA) - Pharmaceutical Trials

Placements24; Stellenbosch; Hybrid; ZAR 420,000 - 660,000; Full time

Benefits offered by this job

Hybrid work model

Travel opportunities for site visits

Competitive salary

Professional development

Retirement fund and medical aid

Job summary

Placements24 is seeking a diligent Clinical Research Associate (CRA) to join a global pharmaceutical operations team in Paarl, Western Cape. The role combines on-site monitoring with remote work, ensuring data integrity, patient safety, and adherence to GCP and regulatory standards.

You will manage site visits, train investigators, oversee CTMS/EDC use, and support trial progress while traveling as required.

Qualifications

• Bachelor’s degree in life science, nursing, or related field.
• Minimum 3 years as a Clinical Research Associate in pharma trials.
• In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
• Experience in site monitoring visits and managing clinical trial sites.
• Excellent organization, communication, and interpersonal skills.

Responsibilities

• Conduct site visits (initiation, monitoring, close-out) per protocol and GCP.
• Verify data accuracy via source data verification (SDV).
• Ensure compliance with study protocols and regulatory standards.
• Train investigative sites on procedures and regulatory expectations.
• Monitor recruitment and retention to meet enrollment targets.
• Oversee handling and accountability of investigational products at sites.
• Prepare and present study progress reports to teams and sponsors.
• Report adverse events and protocol deviations promptly.
• Maintain regulatory documentation at clinical sites.

Skills

Clinical monitoring

GCP knowledge

SDV / data integrity

CTMS

EDC

Travel readiness

Regulatory awareness

Education

Bachelor's degree in life science

Tools

CTMS

EDC

Job description

About the Role

Our client, a globally recognized pharmaceutical organization, is actively seeking a dedicated and experienced Clinical Research Associate (CRA) to join their expanding clinical operations team in Paarl, Western Cape. This vital role involves monitoring and managing clinical trials to ensure data integrity, patient safety, and adherence to protocol and regulatory standards. The ideal candidate will possess a strong understanding of clinical trial processes, Good Clinical Practice (GCP) guidelines, and possess excellent organizational and interpersonal skills. This hybrid position offers the flexibility to work both remotely and from our client's local office, providing a balanced approach to on-site and off-site responsibilities. You will play a crucial part in advancing new pharmaceutical treatments through rigorous clinical investigation. We are looking for a proactive, meticulous individual who can effectively manage site relationships, oversee trial progress, and ensure compliance across all trial activities. This is an excellent opportunity to make a significant impact on drug development and patient care.

Key Responsibilities

• Conduct site visits (initiation, monitoring, close-out) in accordance with study protocols and GCP guidelines.
• Verify the accuracy, completeness, and consistency of clinical data through source data verification.
• Ensure compliance with study protocols, regulatory requirements, and ethical principles.
• Manage and train investigative sites on study procedures, ensuring adherence to protocols and regulatory standards.
• Monitor subject recruitment and retention, working with sites to achieve enrollment targets.
• Oversee the proper handling, storage, and accountability of investigational products at clinical sites.
• Prepare and present study progress reports to the project team and management.
• Identify and report adverse events and protocol deviations promptly.
• Build and maintain strong working relationships with investigators, site staff, and study sponsors.
• Ensure all regulatory documentation is maintained and up-to-date at clinical sites.

Requirements

• Bachelor's degree in a life science, nursing, or related healthcare field.
• Minimum of 3 years of experience as a Clinical Research Associate (CRA) or equivalent role in pharmaceutical clinical trials.
• In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
• Proven experience in conducting site monitoring visits and managing clinical trial sites.
• Strong understanding of medical terminology and clinical trial processes.
• Excellent organizational, time management, and problem-solving skills.
• Exceptional written and verbal communication and interpersonal skills.
• Ability to travel to clinical sites as required.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Detail-oriented with a commitment to data accuracy and patient safety.

Benefits

• Competitive salary commensurate with experience and a comprehensive benefits package.
• Hybrid work model offering flexibility between remote and office-based work.
• Opportunities for professional growth and career advancement within a leading pharmaceutical company.
• Continuous training and development in clinical research practices.
• Exposure to diverse and innovative clinical trials.
• Travel opportunities for site monitoring.
• Contribution to bringing new and essential medicines to patients.
• Retirement fund and medical aid benefits.
• Supportive team environment and experienced leadership.
• Annual performance reviews and potential for bonuses.