Clinical Research Associate (CRA) - Pharmaceutical Trials

Placements24; Centurion; Hybrid; ZAR 600.000 - 950.000; Vollzeit

Benefits dieser Stelle

Health insurance

Life insurance

Disability coverage

Annual leave

Training opportunities

Work-life balance

Zusammenfassung

Placements24 in Centurion, Gauteng, is seeking a dedicated Clinical Research Associate to monitor sites, ensure data integrity, and uphold GCP standards.

You will perform site selection, initiation, monitoring, and close-out visits; manage CTMS and EDC systems; travel up to 50%; and collaborate with investigators and sponsors.

The ideal candidate holds a life sciences related degree, 3–5 years of CRA experience, and is familiar with ICH/GCP; certification such as ACRP/SoCRA is advantageous.

Qualifikationen

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• 3–5 years of CRA experience in the pharmaceutical industry.
• In-depth understanding of GCP, ICH guidelines, and local regulatory requirements.
• Experience conducting site monitoring visits and managing multiple trials.

Aufgaben

• Conduct site monitoring visits (selection, initiation, monitoring, close-out) per GCP.
• Verify data integrity via source data verification and CRF reviews.
• Monitor patient safety and report adverse events.
• Ensure compliance with study protocol, regulations, and SOPs.
• Maintain strong relationships with investigators, site staff, and sponsors.
• Manage investigational product accountability and storage.

Kenntnisse

Communication skills

Interpersonal skills

Organizational skills

Attention to detail

Analytical skills

Ausbildung

Bachelor's degree in Life Sciences

Nursing

Pharmacy

Tools

CTMS

EDC systems

Jobbeschreibung

About the Role

Our client, a renowned pharmaceutical company with a strong commitment to advancing medical treatments, is seeking a dedicated and meticulous Clinical Research Associate (CRA) to join their operations based in Centurion, Gauteng. This role is fundamental to ensuring the successful execution of clinical trials, guaranteeing data integrity, patient safety, and compliance with all regulatory standards. As a CRA, you will be responsible for monitoring investigational sites, verifying that trial protocols are followed, and managing all aspects of site management. This is an exciting opportunity to be part of a team that is at the forefront of medical innovation, contributing directly to the development of new therapies that improve lives. The Centurion area provides a strategic location with excellent connectivity, supporting the company's extensive network of clinical trial sites across the region.

Key Responsibilities

• Conduct site selection, initiation, monitoring, and close-out visits in accordance with Good Clinical Practice (GCP) guidelines.
• Ensure the accurate and timely collection of clinical data through source data verification and review of case report forms (CRFs).
• Monitor patient safety and report adverse events promptly to the relevant stakeholders.
• Verify compliance with the study protocol, relevant regulations, and Standard Operating Procedures (SOPs).
• Build and maintain strong working relationships with investigators, site staff, and study sponsors.
• Manage investigational product accountability and ensure proper storage and handling.
• Troubleshoot and resolve site-level issues to ensure study milestones are met.
• Prepare detailed monitoring visit reports and follow up on action items.
• Ensure all study-related documentation is maintained accurately and organized in site and central files.
• Contribute to the development and review of study protocols and other relevant documents.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• Minimum of 3-5 years of experience as a Clinical Research Associate in the pharmaceutical industry.
• In-depth understanding of GCP, ICH guidelines, and local regulatory requirements.
• Proven experience in conducting site monitoring visits and managing multiple clinical trials simultaneously.Excellent communication, interpersonal, and organizational skills.
• Strong attention to detail and ability to analyze and interpret clinical data.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to clinical sites as required (up to 50%).
• Problem-solving skills and the ability to work independently with minimal supervision.
• Current certification (e.g., ACRP, SoCRA) is an advantage.

Benefits

• Our client offers a competitive salary package, including performance-based incentives.
• Comprehensive health insurance, life insurance, and disability coverage are provided.
• Employees receive a generous annual leave allowance and are eligible for participation in the company's retirement savings plan.
• Opportunities for professional growth through training, certifications, and attendance at industry conferences are actively supported.
• A collaborative and supportive work environment is fostered, with a focus on work-life balance.
• The Centurion location provides excellent access to major transport routes and amenities.