Senior Clinical Research Associate (Hybrid) – Stellenbosch

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

Benefits offered by this job

Medical aid

Retirement fund

Paid time off

Professional development opportunities

Bonuses

Job summary

Placements24 is seeking a highly experienced Senior Clinical Research Associate (CRA) to oversee and manage clinical trials from our Stellenbosch office in the Western Cape. The role combines on-site monitoring with remote flexibility, supporting protocol adherence and regulatory requirements.

You will monitor sites, ensure data integrity, train junior CRAs, and contribute to trial documentation and study lifecycles. A strong background in GCP/ICH and 5+ years in pharma is essential.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related healthcare discipline.
• Minimum 5 years of experience as a Clinical Research Associate in the pharmaceutical industry.
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
• Proven experience in monitoring clinical trials across various therapeutic areas.
• Demonstrated ability to conduct effective site initiation, monitoring, and close-out visits.
• Excellent organizational, time management, and problem-solving skills.
• Strong interpersonal and communication skills, with the ability to build rapport with diverse stakeholders.
• Proficiency in CTMS and EDC systems.
• Willingness to travel extensively to clinical sites as required.

Responsibilities

• Conduct site initiation visits, routine monitoring visits, and close-out visits at clinical trial sites.
• Ensure accurate and timely data collection, source document verification, and query resolution.
• Verify that study conduct is in compliance with the protocol, SOPs, Good Clinical Practice (GCP), and all applicable regulatory requirements.
• Build and maintain strong working relationships with investigators, site staff, and study sponsors.
• Identify and report potential protocol deviations, adverse events, and safety concerns in a timely manner.
• Manage investigational product accountability and ensure proper handling and storage.
• Train and mentor junior CRAs and site personnel on study-specific procedures.
• Contribute to the development of clinical trial protocols, case report forms (CRFs), and monitoring plans.
• Prepare monitoring visit reports and ensure effective communication with study teams.
• Participate in investigator meetings and provide essential site support throughout the study lifecycle.

Skills

GCP/ICH knowledge

Site monitoring

Travel-ready

Stakeholder communication

Education

Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related healthcare discipline

Tools

CTMS

EDC

Job description

Placements24 is seeking a highly experienced Senior Clinical Research Associate (CRA) to oversee and manage clinical trials from our Stellenbosch office in the Western Cape. The role combines on-site monitoring with remote flexibility, supporting protocol adherence and regulatory requirements.

You will monitor sites, ensure data integrity, train junior CRAs, and contribute to trial documentation and study lifecycles. A strong background in GCP/ICH and 5+ years in pharma is essential.