Clinical Research Associate (CRA) - On-Site Support

Placements24; Benoni; On-site; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Medical aid

Performance bonuses

Career development opportunities

Job summary

Placements24 is seeking a diligent Clinical Research Associate (CRA) for an on-site role in Benoni, Gauteng. You will oversee clinical trial sites, ensure data accuracy and patient safety, and maintain study documentation in line with study protocols and regulatory requirements.

You will travel locally up to 60%, monitor sites, train staff, and support investigator meetings. A life sciences/healthcare degree and at least 3 years of CRA experience are required.

Qualifications

• Bachelor’s degree in life sciences or healthcare-related field.
• Minimum 3 years as a CRA or similar clinical trial monitoring role.
• Solid knowledge of ICH-GCP and regulatory requirements.
• Experience monitoring trial sites and managing study documents.

Responsibilities

• Conduct site visits (pre-study, initiation, monitoring, close-out) to ensure data quality.
• Verify data accuracy by comparing source data with source documents.
• Ensure protocol and regulatory compliance per FDA/EMA/ICH-GCP and SOPs.
• Screen and consent patients, and train site staff on procedures.
• Maintain essential study documents and manage drug accountability.
• Identify and escalate data quality or safety issues to the PM.

Skills

Site monitoring

CTMS

EDC

Travel readiness

Education

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

Tools

CTMS

EDC

Job description

About the Role

Our client, a leading Contract Research Organization (CRO) supporting the global Pharmaceutical and Biotechnology industries, is seeking a diligent and experienced Clinical Research Associate (CRA) for an on-site role based in Benoni, Gauteng. This position is vital for overseeing and managing clinical trials at investigator sites, ensuring data accuracy, patient safety, and compliance with study protocols and regulatory requirements. The CRA will act as the primary point of contact for clinical sites, fostering strong relationships and driving study progress. This is an excellent opportunity to contribute to critical research efforts in Benoni and advance your career in clinical research management within the vibrant Pharmaceutical sector.

Key Responsibilities

• Conduct pre-study, initiation, interim monitoring, and close-out visits at clinical trial sites.
• Verify the accuracy, completeness, and consistency of source data and reported data through comparison with source documents.
• Ensure compliance with the protocol, FDA/EMA regulations, ICH-GCP guidelines, and company SOPs.
• Screen, recruit, and consent patients for clinical trials, ensuring adherence to inclusion/exclusion criteria.
• Train site staff on study procedures, protocols, and regulatory requirements.
• Manage and maintain essential study documents at the site level.
• Identify, resolve, or escalation issues related to data quality, patient safety, or regulatory compliance.
• Oversee study drug accountability and administration.
• Report study progress, site performance, and any identified risks to the Clinical Project Manager.
• Build and maintain strong working relationships with investigators and site staff.
• Participate in investigator meetings and provide training as required.
• Ensure timely submission of study-related documentation.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
• Minimum of 3 years of experience as a Clinical Research Associate (CRA) or in a similar clinical trial monitoring role.
• Thorough understanding of ICH-GCP guidelines and regulatory requirements for clinical trials.
• Proven experience in conducting site monitoring visits and managing clinical trial sites.
• Excellent interpersonal, communication, and organizational skills.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel up to 60% locally and potentially internationally (as required by study needs).
• Detail-oriented with strong problem-solving capabilities.
• Experience in the Gauteng region, specifically Benoni, is beneficial.
• Understanding of various therapeutic areas within the Pharmaceutical industry is an asset.

Benefits

• Our client offers a competitive salary, a comprehensive benefits package including medical aid, performance bonuses, and excellent opportunities for professional development and career growth in clinical research.
• This role offers the chance to work on diverse and impactful Pharmaceutical studies.
• The position is based in Benoni, providing a dynamic work environment.
• Join a team dedicated to advancing medical science and improving patient lives.