Lead Clinical Research Associate - Cape Town

Placements24; Cape Town; Hybrid; ZAR 900,000 - 1,400,000; Full time

Benefits offered by this job

Hybrid work arrangement

Competitive compensation

Medical insurance

Retirement savings plan

Professional development

Travel reimbursement

Job summary

Placements24 is seeking a Lead Clinical Research Associate for a global CRO role based in Cape Town, blending on-site oversight with remote flexibility. You will supervise site monitoring, ensure protocol compliance, mentor junior CRAs, and collaborate with study teams to drive trial execution.

The ideal candidate has 5+ years as a CRA, hands-on ICH-GCP knowledge, strong leadership and communication, and the ability to manage multiple sites in a hybrid work environment.

Qualifications

• Bachelor's degree in life sciences or nursing; advanced degree preferred.
• Minimum 5 years as a Clinical Research Associate with 1–2 years in a Lead CRA or supervisory role.
• Strong knowledge of ICH-GCP guidelines and local regulatory requirements.
• Proven ability to conduct remote and on-site monitoring visits.

Responsibilities

• Lead site initiation, monitoring, and close-out visits per protocol and ICH-GCP.
• Ensure accurate data collection and reporting for trials.
• Verify source data and documentation at investigational sites for accuracy and compliance.
• Mentor junior CRAs and collaborate with investigators and study teams.
• Develop study-related documents and monitoring plans; track progress and risks.

Skills

CTMS/EDC

Leadership

Communication

ICH-GCP

Site monitoring

Travel readiness

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

CTMS

EDC systems

Job description

About the Role

Our client, a prominent global Contract Research Organization (CRO), is seeking an experienced and dedicated Lead Clinical Research Associate (CRA) to oversee clinical trial operations in **Cape Town**, Western Cape. This hybrid role requires a professional who can effectively balance remote work flexibility with essential on-site responsibilities, including site visits and team collaborations. You will be instrumental in ensuring the successful execution of clinical studies by monitoring investigational sites, ensuring compliance with protocols, and maintaining data integrity. As a Lead CRA, you will also mentor junior CRAs, contribute to strategic planning, and serve as a key point of contact for study teams and investigational sites. This is a challenging yet rewarding position for a seasoned professional looking to advance their career within a supportive and growth-oriented environment, contributing to life-saving medical advancements.

Key Responsibilities

• Manage and conduct site initiation, monitoring, and close-out visits in compliance with study protocols, ICH-GCP guidelines, and local regulations.
• Ensure accurate, complete, and timely collection and reporting of clinical trial data, overseeing data management activities.
• Verify source data and documentation at investigational sites for accuracy, completeness, and compliance.
• Build and maintain strong relationships with investigators, site staff, and other study personnel.
• Identify, evaluate, and qualify potential investigational sites, ensuring they meet study requirements.
• Oversee subject recruitment and retention efforts, collaborating with sites to address challenges.
• Train and mentor junior CRAs on study procedures, regulatory requirements, and best practices.
• Participate in the development of study-related documents, including protocols, case report forms (CRFs), and monitoring plans.
• Track study progress, identify potential risks and issues, and implement mitigation strategies to ensure timely study completion.
• Prepare and present study status reports, highlighting key findings and action items for project management and sponsors.

Requirements

• Bachelor's degree in a life science, nursing, or a related scientific discipline. Advanced degree preferred.
• Minimum of 5 years of progressive experience as a Clinical Research Associate, with at least 1-2 years in a Lead CRA or similar supervisory role.
• Extensive knowledge of ICH-GCP guidelines, local regulatory requirements, and clinical trial processes.
• Proven ability to conduct all types of site monitoring visits (remote and on-site).
• Strong understanding of medical terminology and clinical trial procedures.
• Excellent communication, interpersonal, and presentation skills.
• Demonstrated leadership capabilities and experience mentoring junior staff.
• Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
• Ability to travel as required for site visits and meetings, adhering to a hybrid work model.
• Strong organizational and time management skills, with the ability to manage multiple priorities effectively.

Benefits

• Competitive annual salary package of R.
• Hybrid work arrangement offering flexibility and balance.
• Comprehensive medical, dental, and vision insurance.
• Retirement savings plan with attractive company contributions.
• Opportunities for continuous professional development and training.
• Performance-based bonuses and potential for career advancement within a global organization.
• Reimbursement for travel expenses related to site visits.
• Supportive team environment focused on collaborative success.