Senior Clinical Research Associate - Randburg

Placements24; Southampton; Hybride; GBP 27 000 - 40 000; Plein temps

Résumé du poste

Unknown CRO is seeking an experienced Senior Clinical Research Associate to support clinical trials in Randburg and surrounding areas. The role emphasizes adherence to GCP, regulatory standards, and robust data management while fostering strong relationships with investigators and staff.

The candidate will conduct initiation, monitoring, and close-out visits, review CRFs, and ensure proper documentation and drug accountability. Travel to sites is required.

Qualifications

• Bachelor’s degree in a life science, nursing, or related field.
• 4–5 years of CRA experience in pharma or CRO settings.
• Strong knowledge of ICH-GCP and regulatory requirements.

Responsabilités

• Perform site monitoring, initiation, routine visits and close-out activities.
• Review source documents and CRFs to ensure data accuracy and integrity.
• Maintain proactive communication with investigators and site staff.
• Ensure proper drug accountability and submission of essential documents.
• Identify and escalate study risks and deviations to project management.
• Assist in study document preparation and monitoring plan development.
• Train site staff on procedures and data capture requirements.
• Participate in investigator meetings and teleconferences as needed.
• Contribute to risk-based monitoring strategies.

Connaissances

ICH-GCP knowledge

Clinical monitoring

Stakeholder management

Data integrity

CTMS experience

Formation

Bachelor's degree in life science or nursing

Outils

CTMS

EDC

Description du poste

About the Role

Our client, a rapidly growing Contract Research Organization (CRO), is seeking an experienced Senior Clinical Research Associate (CRA) to join their dedicated team, supporting operations in the Randburg, Gauteng area. This role is integral to the successful execution of clinical trials, ensuring adherence to Good Clinical Practice (GCP), regulatory requirements, and study protocols. The Senior CRA will be responsible for site monitoring, data management, and fostering strong relationships with investigators and study staff. This is an exceptional opportunity for a seasoned clinical research professional to advance their career within a dynamic and supportive organization, contributing to the development of life-saving therapies.

Key Responsibilities

• Conduct site initiation, routine monitoring, and close-out visits to ensure compliance with study protocols, GCP, and applicable regulations.
• Verify the accuracy, completeness, and integrity of clinical data by reviewing source documents and case report forms (CRFs).
• Manage communication and relationships with clinical trial sites, investigators, and study coordinators.
• Ensure timely submission of essential documents and proper drug accountability at study sites.
• Identify, document, and escalate study-related issues, deviations, and potential risks to project management.
• Assist in the preparation of study documents, including protocols, informed consent forms, and monitoring plans.
• Train site personnel on study procedures, protocols, and data collection requirements.
• Participate in investigator meetings and teleconferences as required.
• Contribute to the development and implementation of risk-based monitoring strategies.

Requirements

• Bachelor's degree in a life science, nursing, or a related healthcare field.
• A minimum of 4-5 years of experience as a Clinical Research Associate in pharmaceutical or CRO settings.
• In-depth knowledge of ICH-GCP guidelines and applicable regulatory requirements.
• Proven experience in monitoring clinical trials across various therapeutic areas.
• Strong understanding of clinical trial processes, including site management and data management.
• Excellent organizational, time management, and multitasking skills.
• Exceptional interpersonal and communication skills, with the ability to build rapport with site staff.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to clinical sites as required within the Randburg region and surrounding areas.
• Must be legally authorized to work in South Africa.

Benefits

Our client offers a competitive salary, comprehensive health and wellness benefits, performance-based bonuses, and extensive opportunities for professional development and career growth. You will join a respected CRO dedicated to advancing medical research and contributing to global health initiatives. This role offers a challenging and rewarding career within the vibrant business landscape of Randburg.