Senior Clinical Research Associate — Trials Lead

Placements24; Mossel Bay; On-site; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Healthcare benefits

Retirement plan

Professional development

Job summary

Placements24 seeks a Senior Clinical Research Associate to oversee trial conduct in Mossel Bay, ensuring GCP compliance and patient safety. You will monitor sites, manage data integrity, and mentor junior CRAs, traveling extensively within the region.

You'll collaborate with investigators and staff, maintain regulatory files, and ensure timely reporting and QA across studies in a dynamic operations team.

Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy or related discipline.
• Minimum of 5 years as a Clinical Research Associate in pharma/biotech.
• Deep knowledge of ICH-GCP guidelines, trial processes and regulatory requirements.
• Proven experience monitoring sites and ensuring data integrity.
• Strong medical terminology knowledge applicable to current studies.
• Excellent written and verbal communication with strong interpersonal skills.
• Proficient in CTMS and EDC systems.
• Ability to work independently and meet strict deadlines.
• Willingness to travel extensively within the region.

Responsibilities

• Conduct site visits for selection, initiation, monitoring and close-out per protocol and GCP.
• Ensure accurate, timely data collection and source data verification.
• Protect the rights and safety of trial subjects.
• Verify data accuracy and traceability from source documents.
• Maintain relationships with investigators and site staff.
• Oversee study site regulatory files and documentation.
• Identify and report AEs/SAEs promptly.
• Troubleshoot issues and implement corrective actions.
• Ensure adherence to protocols and SOPs and regulatory guidelines.
• Prepare trip reports and track site progress and metrics.

Skills

Site monitoring

GCP knowledge

Data integrity

CTMS

EDC systems

Travel willingness

Mentorship

Education

Bachelor's degree in life sciences

Tools

CTMS

EDC

Job description

Placements24 seeks a Senior Clinical Research Associate to oversee trial conduct in Mossel Bay, ensuring GCP compliance and patient safety. You will monitor sites, manage data integrity, and mentor junior CRAs, traveling extensively within the region.

You'll collaborate with investigators and staff, maintain regulatory files, and ensure timely reporting and QA across studies in a dynamic operations team.