Clinical Research Associate (Senior Level)

Placements24; Centurion; Hybrid; ZAR 900,000 - 1,300,000; Full time

Job summary

Placements24 invites applications for a Senior Clinical Research Associate (CRA) to join a rapidly expanding CRO in Centurion, Gauteng. You will monitor clinical sites, ensure protocol and regulatory adherence, and uphold GCP standards across therapeutic areas in South Africa.

The role emphasizes site management, data verification, and subject safety, with leadership in investigator training and cross-team collaboration. A strong background in life sciences and CRO experience is essential.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy or related healthcare field.
• Minimum of 4-6 years of direct CRA experience, with senior-level exposure.
• In-depth knowledge of GCP, ICH guidelines and regulatory requirements.

Responsibilities

• Conduct site initiation, monitoring, and close-out visits according to protocol and regulatory requirements.
• Verify accuracy and completeness of trial data via source data verification.
• Ensure compliance with GCP, FDA regulations, and local regulatory requirements at sites.
• Manage communication between sites, study team, and sponsor.
• Identify and report adverse events, protocol deviations, and safety issues promptly.
• Train and mentor investigators and site staff on procedures and regulatory compliance.
• Maintain accurate trial documentation, including site files and monitoring reports.
• Collaborate with data management and clinical operations to ensure data quality.
• Participate in investigator meetings and provide progress feedback.
• Identify risks to timelines and data quality and implement mitigation strategies.

Skills

GCP knowledge

ICH guidelines

Regulatory compliance

Education

Bachelor's degree in Life Sciences or related field

Job description

About the Role

Our client, a rapidly expanding Contract Research Organization (CRO) specializing in clinical trials, is seeking a highly motivated and experienced Senior Clinical Research Associate (CRA) to join their dedicated team in Centurion, Gauteng.

This role is pivotal in ensuring the successful execution and integrity of clinical studies across various therapeutic areas. The Senior CRA will be responsible for monitoring clinical trial sites, ensuring adherence to protocols, regulatory requirements, and Good Clinical Practices (GCP). You will play a key role in site management, data verification, and subject safety, contributing significantly to the advancement of new medicines. The ideal candidate will possess strong therapeutic area knowledge, exceptional organizational skills, and a proactive approach to problem-solving in a dynamic research environment. This is an exceptional opportunity to advance your career within the clinical research field in South Africa.

Key Responsibilities

• Conduct site initiation, monitoring, and close-out visits according to study protocol and regulatory requirements.
• Verify the accuracy, completeness, and consistency of clinical trial data through source document verification.
• Ensure compliance with GCP, FDA regulations, and local regulatory requirements at assigned clinical sites.
• Manage communication between the clinical trial sites, the study team, and the sponsor.
• Identify and report adverse events, protocol deviations, and other safety issues promptly.
• Train and mentor investigators and site staff on study-specific procedures and regulatory compliance.
• Maintain accurate and organized trial documentation, including site files and monitoring reports.
• Collaborate with data management and clinical operations teams to ensure data quality and integrity.
• Participate in investigator meetings and provide feedback on study conduct and progress.
• Identify potential risks to study timelines and data quality, implementing mitigation strategies.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
• Minimum of 4-6 years of direct experience as a Clinical Research Associate, with a significant portion at a senior level.
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.