Senior Clinical Research Associate (CRA)

Placements24; Sandton; Vor Ort; ZAR 900.000 - 1.200.000; Vollzeit

Benefits dieser Stelle

Health insurance

Retirement plan

Paid time off

Professional growth opportunities

Zusammenfassung

Placements24 in Sandton, Gauteng, seeks a Senior Clinical Research Associate to monitor sites, ensure data integrity, and uphold GCP standards. You will liaise with investigators and sponsors while traveling to investigational sites.

The ideal candidate has 4–6 years CRA experience, strong regulatory knowledge, and proficiency with EDC/CTMS. This on-site role offers growth in a dynamic clinical research environment.

Qualifikationen

• Bachelor’s degree in a scientific, healthcare, or related field.
• 4–6 years as a Clinical Research Associate with successful monitoring.
• Strong knowledge of ICH-GCP guidelines and regulatory requirements.
• Experience across multiple therapeutic areas is a plus.
• Proficient in EDC systems and CTMS.
• Ability to travel 50–70% to investigational sites.

Aufgaben

• Conduct site initiation, interim monitoring, and close-out visits per study plans and GCP.
• Monitor sites for data accuracy, source data verification, and protocol compliance.
• Verify patient safety and proper conduct of trials at sites.
• Manage communications with investigators, site staff, and sponsors.
• Ensure timely collection/review of regulatory binders and CRFs.
• Identify and resolve site-level issues, escalate when needed.
• Train and mentor junior CRAs and site personnel on procedures and GCP.
• Prepare site monitoring reports and progress reports.
• Ensure compliance with regulatory requirements and SOPs.

Kenntnisse

GCP Compliance

Site Monitoring

EDC/CTMS

Communication Skills

Travel 50-70%

Regulatory Knowledge

Ausbildung

Bachelors in science/healthcare

Advanced degree preferred

Tools

EDC Systems

CTMS

Jobbeschreibung

About the Role

Our client, a premier Contract Research Organization (CRO) supporting pharmaceutical and biotechnology companies, is seeking a highly experienced Senior Clinical Research Associate (CRA) to join their expanding operations in Sandton, Gauteng, ZA . This role is integral to the successful execution of clinical trials, ensuring adherence to Good Clinical Practice (GCP) guidelines, study protocols, and regulatory requirements. The Senior CRA will be responsible for monitoring investigational sites, ensuring data accuracy, patient safety, and trial integrity. The ideal candidate possesses exceptional organizational skills, a thorough understanding of clinical trial processes, and a strong commitment to quality. This is a fantastic opportunity to work on diverse and cutting-edge clinical trials, contributing directly to the development of new therapies. You will be a key liaison between our client's sponsors and the clinical research sites, playing a vital role in bringing life-saving treatments to market. We are looking for a dedicated professional to uphold the highest standards of clinical research excellence.

Key Responsibilities

• Conduct site initiation, interim monitoring, and close-out visits in accordance with study plans and GCP.
• Monitor clinical trial sites to ensure data accuracy, source document verification, and protocol compliance.
• Verify patient safety and the proper conduct of the trial at assigned investigational sites.
• Manage communication and relationships with investigators, site staff, and study sponsors.
• Ensure timely collection and review of study-related documents, including regulatory binders and case report forms (CRFs).
• Identify, document, and resolve site-level issues and deviations, escalating as necessary.
• Train and mentor junior CRAs and site personnel on study procedures and GCP.
• Prepare site monitoring reports and contribute to overall study progress reports.
• Ensure compliance with all applicable regulatory requirements and company SOPs.

Requirements

• Bachelor's degree in a scientific, healthcare, or related field; advanced degree preferred.
• A minimum of 4-6 years of experience as a Clinical Research Associate, with demonstrated success in monitoring clinical trials.
• Comprehensive knowledge of ICH-Good Clinical Practice (GCP) guidelines and regulatory requirements.
• Experience across multiple therapeutic areas is a plus.
• Strong understanding of clinical trial conduct, site operations, and data management.
• Excellent communication, interpersonal, and negotiation skills.
• Proficient in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Ability to travel to investigational sites as required (estimated percentage: 50-70%).
• High level of organization, attention to detail, and problem-solving skills.

Benefits

• Competitive salary.
• Comprehensive benefits package including health insurance, retirement contributions, and paid time off.
• Opportunities for professional growth, ongoing training, and exposure to a wide range of clinical research projects.
• Supportive and dynamic work environment within the bustling hub of Sandton, Gauteng, ZA.