Senior Clinical Research Associate - Pharmaceuticals

Placements24; Johannesburg; Hybrid; ZAR 700,000 - 1,000,000; Full time

Benefits offered by this job

Medical aid

Retirement fund

Performance bonuses

Career growth

Job summary

Placements24 in Johannesburg is seeking a Senior Clinical Research Associate to manage sites, monitor trials, and ensure protocol compliance under GCP and regulatory standards.

The role requires 5–7 years CRA experience, strong communication, CTMS/EDC proficiency, and travel of 50–60%. It offers a hybrid work model and comprehensive benefits including medical aid and retirement contributions.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• 5–7 years of CRA experience in the pharmaceutical industry.
• In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
• Proven monitoring experience across therapeutic areas.
• Strong organizational and communication skills.
• Proficiency with CTMS and EDC systems.

Responsibilities

• Conduct site initiation, monitoring, and closure visits per protocol and GCP.
• Assess participant eligibility and ensure informed consent procedures.
• Monitor study conduct, data accuracy and source documents.
• Ensure regulatory compliance with study protocol and FDA/regulatory guidelines.
• Manage site-level issues and escalate to the Clinical Project Manager as needed.
• Build relationships with investigators and site staff.
• Oversee drug accountability and site documentation.
• Prepare monitoring visit reports and follow up on actions.
• Contribute to study protocols and case report forms (CRFs).
• Maintain and archive site-related trial documentation.

Skills

GCP knowledge

CTMS

EDC systems

Data management

Regulatory knowledge

Communication

Travel 50-60%

Clinical trials

Education

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

Job description

About the Role

Our client, a globally recognized pharmaceutical company dedicated to advancing healthcare, is seeking a highly experienced Senior Clinical Research Associate (CRA) to join their team in Johannesburg, Gauteng. This role is integral to the successful execution of clinical trials, ensuring adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements. The Senior CRA will be responsible for site management, monitoring study progress, and ensuring the safety and integrity of clinical data. This hybrid position combines essential on-site responsibilities at clinical trial locations with the flexibility of remote work. You will be contributing to potentially life‑saving therapies within a dynamic and supportive environment.

Key Responsibilities

• Conduct site initiation, interim monitoring, and site closure visits in accordance with the clinical trial protocol and GCP guidelines.
• Assess the eligibility of potential participants and ensure informed consent procedures are followed.
• Monitor study conduct, data accuracy, and source document verification at investigational sites.
• Ensure compliance with the study protocol, FDA regulations, and other applicable regulatory requirements.
• Manage and resolve site-level issues, escalating to the Clinical Project Manager as needed.
• Build and maintain positive relationships with investigators and site staff.
• Oversee drug and investigational product accountability at the study sites.
• Prepare accurate and timely monitoring visit reports and follow‑up on action items.
• Contribute to the development of clinical study protocols and case report forms (CRFs).
• Ensure all site‑related trial documentation is maintained and archived appropriately.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field.
• A minimum of 5-7 years of experience as a Clinical Research Associate in the pharmaceutical industry.
• In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
• Proven experience in monitoring clinical trials across various therapeutic areas.
• Excellent understanding of clinical trial processes, documentation, and data management.
• Strong organizational, time management, and problem‑solving skills.
• Exceptional interpersonal and communication skills, with the ability to build rapport with diverse stakeholders.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to clinical sites as required (approximately 50-60%).
• Experience working within the Gauteng region and familiarity with its healthcare infrastructure is beneficial.

Benefits

• Our client offers a competitive salary and comprehensive benefits package, including excellent medical aid, retirement fund contributions, and performance bonuses.
• Opportunities for professional growth and development, including advanced training and career progression within the pharmaceutical sector, are abundant.

Join a leading pharmaceutical company committed to innovation and improving patient outcomes.