Senior Clinical Research Associate: Site Monitoring Expert

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

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.