Clinical Research Associate (CRA) - Senior

Placements24; Vereeniging; Hybrid; ZAR 700,000 - 900,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Bonus potential

Travel allowance

Paid time off

Professional development

Job summary

Placements24 is seeking a Senior Clinical Research Associate to monitor multi-center trials in Vereeniging, Gauteng. You will ensure trials are conducted, recorded and reported per protocol, GCP, ICH, and regulatory requirements, with patient safety and data integrity as priorities.

You will lead site initiation, monitoring, and close-out visits, manage site relationships, train staff, and mentor junior CRAs to promote best practices across the region.

Qualifications

• Thorough understanding of GCP, ICH guidelines, and regulatory requirements for clinical trials.
• Proven experience in site management, patient recruitment, and data collection.
• Ability to travel 50-70% and work independently across multiple sites.

Responsibilities

• Conduct site initiation, routine monitoring, and close-out visits for clinical trial sites.
• Verify data accuracy and compliance by reviewing source documents and CRFs.
• Ensure adherence to protocols, GCP, and regulatory requirements.
• Mentor junior CRAs and drive best practices in monitoring.

Skills

GCP knowledge

Regulatory compliance

Travel readiness

Education

Bachelor's degree in life science, nursing, or related healthcare field

Tools

CTMS

EDC systems

Job description

About the Role

Our client, a leading contract research organization (CRO) in the pharmaceutical sector, is seeking an experienced Senior Clinical Research Associate (CRA) to join their expanding team. This pivotal role involves monitoring clinical trials to ensure they are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements. The Senior CRA will be responsible for site selection, initiation, monitoring, and close-out visits, ensuring data integrity and patient safety. This position is crucial for the successful execution of clinical trials that bring innovative therapies to patients. The role offers significant autonomy and the opportunity to work on diverse therapeutic areas within the Vereeniging, Gauteng region.

Key Responsibilities

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


• Verify the accuracy, completeness, and compliance of study data by reviewing source documents and case report forms (CRFs).


• Ensure adherence to study protocols, GCP guidelines, and all relevant local and international regulatory requirements.


• Manage site performance, identify potential issues, and implement corrective actions to ensure study timelines and objectives are met.


• Build and maintain strong relationships with investigators, site staff, and study sponsors.


• Train site personnel on study procedures, protocol requirements, and data management.


• Prepare monitoring visit reports and communicate findings effectively to the clinical trial team.


• Oversee resolution of data queries and ensure timely database lock.


• Manage essential study documents and ensure site compliance with regulatory requirements.


• Act as a mentor to junior CRAs and contribute to the development of monitoring best practices within the Vereeniging area.

Requirements

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


• A minimum of 5 years of experience as a Clinical Research Associate, with demonstrated experience in monitoring multi-center clinical trials.


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


• Proven experience in site management, patient recruitment, and data collection.


• Excellent communication, interpersonal, and problem-solving skills.


• Ability to manage multiple priorities, work independently, and travel as required (approximately 50-70%).


• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.


• Strong organizational skills and meticulous attention to detail.


• Experience in specific therapeutic areas is a plus.


• Commitment to patient safety and data integrity in clinical research conducted in Gauteng .

Benefits

• Competitive annual salary of R.


• Comprehensive medical, dental, and vision insurance plans.


• Performance-based bonuses and potential for career advancement.


• Generous travel allowance and expense reimbursement.


• Paid time off and company holidays.


• Opportunities for ongoing professional development and training.


• Retirement savings plan.


• A dynamic and collaborative work environment with a global reach.


• The opportunity to contribute to bringing life-saving therapies to market from Vereeniging .