Senior Clinical Research Associate (CRA)

Placements24; Pretoria; On-site; ZAR 900,000 - 1,100,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Retirement savings plan

Paid time off

Professional development

Job summary

Placements24 is seeking a Senior Clinical Research Associate (CRA) to join a dynamic CRO in Pretoria, Gauteng. The role involves management and monitoring of clinical trials, ensuring data integrity, patient safety, and regulatory compliance across multiple sites.

The Senior CRA will perform site initiation, monitoring, and close-out visits, maintain study documentation, and collaborate with investigators and sponsors. Travel across Pretoria and surrounding regions is required.

Qualifications

• Bachelor's degree in life science, nursing, or related field.
• 4-6 years of CRA experience with ICH-GCP knowledge.
• Experience monitoring multiple sites independently.
• Strong understanding of clinical trial processes and regulatory requirements.
• Excellent organizational and communication skills.
• Willingness to travel extensively within Pretoria and surrounding regions.

Responsibilities

• Conduct site visits (initiation, routine monitoring, close-out) per protocol and GCP guidelines.
• Verify data accuracy through source data verification.
• Ensure adherence to study protocols and regulatory requirements at sites.
• Identify and resolve site-level issues and discrepancies.
• Coordinate communication between sites, operations, and sponsors.
• Train and mentor site staff on procedures and compliance.
• Prepare monitoring visit reports and action items.
• Oversee drug accountability at study sites.
• Contribute to development and review of trial documentation.
• Resolve site queries and follow up on actions.

Skills

ICH-GCP knowledge

Site monitoring

CTMS

EDC systems

Excellent communication

Organizational skills

Travel readiness

Education

Bachelor's degree in life sciences/nursing/related field

Tools

CTMS

EDC

Job description

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About the Role

Our client, a dynamic Contract Research Organization (CRO) deeply embedded in the pharmaceutical sector, is actively seeking an experienced Senior Clinical Research Associate (CRA) to join their expanding operations in **Pretoria, Gauteng**. This vital role involves managing and monitoring clinical trials to ensure data integrity, patient safety, and adherence to protocols and regulatory guidelines. The Senior CRA will be responsible for site selection, initiation, monitoring, and closure activities, working closely with investigators and site staff to guarantee the successful execution of clinical studies. This position requires a highly organized, detail-oriented professional with a proven ability to manage multiple sites and complex trials. Your contribution in **Pretoria, Gauteng** will directly impact the timely and accurate delivery of critical clinical data for drug development. We are looking for individuals passionate about advancing medical science and dedicated to upholding the highest standards of clinical research ethics and practice. This role offers a challenging yet rewarding career path with significant opportunities for growth within a leading CRO.

Key Responsibilities

• Conduct site visits (initiation, routine monitoring, close-out) according to protocol and GCP guidelines.
• Verify the accuracy, completeness, and consistency of clinical data through source document verification.
• Ensure adherence to study protocols, regulatory requirements, and company SOPs at investigational sites.
• Identify, assess, and resolve site-level issues and discrepancies.
• Manage communication between study sites, the clinical operations team, and sponsors.
• Train and mentor site staff on study-specific procedures and regulatory compliance.
• Prepare and present monitoring visit reports and action items.
• Oversee drug accountability and investigational product management at study sites.
• Contribute to the development and review of clinical trial documentation.
• Ensure timely resolution of site queries and follow-up on action items.

Requirements

• Bachelor's degree in a life science, nursing, or related field.
• Minimum of 4-6 years of experience as a Clinical Research Associate, with a strong understanding of ICH-GCP guidelines.
• Proven experience in monitoring multiple clinical trial sites independently.
• Excellent understanding of clinical trial processes, documentation, and regulatory requirements.
• Strong organizational, time management, and problem-solving skills.
• Exceptional written and verbal communication skills.
• Proficiency with clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
• Ability to build and maintain positive relationships with investigators and site staff.
• Self-motivated, adaptable, and able to work effectively under pressure.
• Willingness to travel extensively within **Pretoria, Gauteng** and surrounding regions as required.

Benefits

• Our client offers a competitive salary commensurate with experience, along with a comprehensive benefits package that includes health, dental, and vision insurance, a retirement savings plan, and paid time off.
• Opportunities for professional development, including advanced CRA training and certification support, are provided.
• This role offers the flexibility to manage your schedule and work within the vibrant city of **Pretoria, Gauteng**.
• We foster a collaborative and supportive team environment, empowering our CRAs to excel.
• You will have the opportunity to work on diverse and impactful clinical trials, contributing to the advancement of healthcare.
• Further details on compensation and benefits will be shared during the interview process.