Senior Clinical Research Associate (CRA) - Pharmaceutical

Placements24; Midrand; Hybrid; ZAR 800,000 - 1,200,000; Full time

Benefits offered by this job

Medical aid

Retirement fund

Paid time off

Professional development

Hybrid work model

Access to R&D projects

Job summary

Placements24 is seeking a Senior Clinical Research Associate in Midrand, Gauteng. The role focuses on site visits, regulatory compliance, data integrity, and cross-functional collaboration in a hybrid work model.

The ideal candidate has 5+ years of CRA experience, strong ICH-GCP knowledge, and readiness to travel up to 60% to sites in and around Midrand. A life sciences degree is required, with advanced degrees a plus.

Qualifications

• Bachelor’s degree in life science, nursing, pharmacy, or related discipline is required.
• Advanced degree is a plus.
• Minimum of 5 years of experience as a Clinical Research Associate in pharma.
• Experience in oncology, cardiology, or immunology desirable.
• In-depth knowledge of ICH-GCP and SA regulatory requirements.

Responsibilities

• Conduct site visits (initiation, monitoring, close-out) to ensure adherence to protocols and data accuracy.
• Train and mentor junior CRAs and ensure regulatory compliance.
• Oversee site personnel and study procedures.
• Manage data discrepancies and ensure data integrity.
• Coordinate with investigators and project teams for study progress.

Skills

GCP compliance

CTMS

EDC systems

Site monitoring

Travel readiness

Education

Bachelor’s degree in life science/related field

Advanced degree (plus)

Tools

CTMS software

EDC platforms

Job description

About the Role

Our client, a leading pharmaceutical innovator, is seeking a highly skilled and experienced Senior Clinical Research Associate (CRA) to join their dynamic team in Midrand, Gauteng . This role is pivotal in ensuring the successful execution of clinical trials, adhering to rigorous quality standards and regulatory requirements. The Senior CRA will play a critical role in the drug development lifecycle, contributing to bringing life-saving therapies to patients. This is an exciting opportunity for a seasoned professional to advance their career within a reputable organization. The position involves a hybrid work model, offering a balance between remote flexibility and in-person collaboration. You will be integral to maintaining the integrity and accuracy of clinical data, supporting our client's commitment to excellence in pharmaceutical research.

Key Responsibilities

• Conduct site visits (initiation, monitoring, close-out) to ensure study protocols are followed and data is accurate.
• Train and mentor junior CRAs, providing guidance on study conduct and regulatory compliance.
• Oversee site personnel, ensuring they are qualified and trained on the investigational product and study procedures.
• Manage data discrepancies, ensuring timely resolution and data integrity.
• Liaise effectively with investigators, site staff, and internal project teams to ensure efficient study progress.
• Prepare and present site monitoring reports and review essential documents.
• Ensure compliance with Good Clinical Practice (GCP), FDA regulations, and other applicable guidelines.
• Contribute to the development and review of study-related documents, such as protocols and informed consent forms.

Requirements

• A Bachelor's degree in a life science, nursing, pharmacy, or a related discipline is required.
• An advanced degree is a plus.
• Minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical industry.
• Proven experience in therapeutic areas such as oncology, cardiology, or immunology is highly desirable.
• In-depth knowledge of ICH-GCP guidelines and regulatory requirements in South Africa .
• Excellent understanding of clinical trial processes from start-up to close-out.
• Strong organizational, time management, and problem-solving skills.
• Excellent communication and interpersonal skills, with the ability to build rapport with site personnel and stakeholders.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Willingness to travel to clinical sites as required, up to 60% of the time, in and around Midrand .

Benefits

• Competitive annual salary with performance-based bonuses.
• Comprehensive medical aid and retirement fund contributions.
• Generous paid time off and holiday leave.
• Opportunities for professional development, including advanced training and certifications.
• Access to cutting-edge research and development projects.
• A supportive and collaborative work environment.
• Hybrid work arrangement for a better work-life balance.