Clinical Research Associate (Pharmaceuticals)

Placements24; Stellenbosch; Hybrid; ZAR 520,000 - 750,000; Full time

Benefits offered by this job

Hybrid work arrangement

Competitive salary and incentives

Health, dental, vision insurance

Job summary

Placements24 is seeking an experienced Clinical Research Associate (CRA) to join our client’s team in Stellenbosch. The role blends on-site responsibilities with remote flexibility, focusing on site initiation, monitoring, and close-out visits to ensure trial data quality and participant safety.

The CRA will ensure adherence to the study protocol, SOPs, GCP, and regulatory standards, acting as a liaison between sponsor and sites and addressing issues in collaboration with the clinical project

Qualifications

• Bachelor’s degree in life sciences or related field required; advanced degree preferred.
• Minimum 3 years in CRA or similar clinical research role in pharma.
• Strong understanding of GCP, ICH guidelines, and SA regulatory requirements.
• Excellent monitoring, data verification, and site management skills.

Responsibilities

• Conduct site initiation, routine monitoring, and close-out visits.
• Ensure compliance with protocol, SOPs, GCP, and regulatory requirements.
• Verify accuracy and integrity of data via SDV.
• Act as primary liaison between sponsor and investigative sites.
• Manage site-level issues and escalate to the clinical project manager as needed.

Skills

Site initiation

Monitoring

Data verification

GCP/ICH familiarity

Regulatory knowledge

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

About the Role

Our client, a forward-thinking pharmaceutical company , is seeking an experienced Clinical Research Associate (CRA) to join their team in Stellenbosch . This role is pivotal in managing and monitoring clinical trials to ensure they are conducted, recorded, and reported in accordance with the study protocol, standard operating procedures (SOPs), and regulatory guidelines. You will be responsible for site initiation, monitoring, and close-out visits, ensuring data integrity and patient safety throughout the trial lifecycle. The position offers a blend of on-site responsibilities and remote flexibility, contributing to the advancement of innovative pharmaceutical treatments .

Key Responsibilities

• Conduct site initiation, routine monitoring, and close-out visits for clinical trial sites.


• Ensure compliance with protocol, SOPs, GCP (Good Clinical Practice), and all applicable regulatory requirements.


• Verify the accuracy, completeness, and integrity of clinical trial data through source data verification (SDV).


• Act as the primary liaison between the sponsor and the investigative sites, fostering positive working relationships.


• Manage and resolve site-level issues and elevate critical issues to the clinical project manager as needed.

Requirements

• Bachelor's degree in a life science, nursing, or related field. Advanced degree preferred.


• Minimum of 3 years of experience as a CRA or in a similar clinical research role within the pharmaceutical industry .


• Thorough understanding of GCP, ICH guidelines, and regulatory requirements for clinical trials in South Africa .


• Excellent monitoring skills, including site management and data verification.


• Strong communication, organizational, and problem-solving abilities.

Benefits

• Competitive salary and performance-based incentives.


• Hybrid work arrangement providing flexibility and work-life balance.


• Comprehensive health, dental, and vision insurance plans.


• Opportunities for international travel and professional development.


• Supportive work environment with a focus on career growth in clinical research.