Lead Clinical Research Associate

Placements24; Noord-Kaap; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement plan

Hybrid work arrangement

Career growth opportunities

Job summary

Placements24 is seeking a highly organized Lead Clinical Research Associate to oversee clinical trial activities in the Kimberley region. In this hybrid role, you will lead a team of CRAs, ensuring compliance with study protocols, regulatory guidelines, and company standards.

You will manage site performance, monitor progress, review data, and serve as the primary contact between sites, sponsors, and vendors, contributing to the safe and timely execution of studies.

Qualifications

• Bachelor’s degree in life science, nursing, or related field.
• Minimum of 5 years as a Clinical Research Associate with leadership experience.
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements.

Responsibilities

• Lead and mentor a team of CRAs, providing training and oversight.
• Plan, manage, and execute monitoring activities at sites.
• Ensure adherence to GCP and regulatory guidelines.
• Conduct site initiation, interim monitoring, and close-out visits.
• Review data, source documents, and CRFs for accuracy.

Skills

Team leadership

Clinical monitoring

GCP knowledge

Travel readiness

Education

Bachelor’s in life sciences

Advanced degree preferred

Job description

About the Role

Our client is seeking a highly organized and experienced Lead Clinical Research Associate (CRA) to oversee clinical trial activities in the Kimberley region. In this hybrid role, you will lead a team of CRAs, ensuring compliance with study protocols, regulatory guidelines, and company standards. You will be responsible for site management, monitoring trial progress, and ensuring the safety and integrity of study data. This position requires strong leadership skills, meticulous attention to detail, and a comprehensive understanding of clinical trial operations. You will play a vital role in the successful execution of clinical studies, contributing to the advancement of new medical treatments.

Key Responsibilities

• Lead and mentor a team of Clinical Research Associates, providing training and oversight.
• Plan, manage, and execute clinical trial monitoring activities at assigned sites.
• Ensure adherence to Good Clinical Practice (GCP) guidelines and all applicable regulations.
• Conduct site initiation, interim monitoring, and close-out visits.
• Review and verify clinical data, source documents, and case report forms for accuracy and completeness.
• Serve as the primary point of contact for study sites and manage communication between sites, sponsors, and vendors.

Requirements

• Bachelor's degree in a life science, nursing, or a related field; advanced degree preferred.
• Minimum of 5 years of experience as a Clinical Research Associate, with demonstrated leadership experience.
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
• Experience with various therapeutic areas and clinical trial phases.
• Excellent communication, interpersonal, and organizational skills.
• Ability to travel to study sites as required.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Retirement plan with company match.
• Hybrid work arrangement offering flexibility.
• Opportunities for professional development and career growth.