Senior Clinical Research Associate - Phase III Trials

Placements24; Durban; Híbrido; ZAR 700 000 - 1 100 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Retirement savings plan

Professional development

Resumo da oferta

Placements24 in Durban is seeking a Senior Clinical Research Associate to oversee Phase III trials, ensure GCP compliance, and monitor sites. You will manage monitoring visits, verify data, and safeguard participant safety.

The role requires a life science or nursing degree, 5+ years as a CRA, and proficiency with CTMS/EDC. Willingness to travel to trial sites is essential.

Qualificações

• Bachelor's degree in a life science, nursing, or related field.
• Minimum 5 years as a Clinical Research Associate with significant Phase III experience.
• In-depth knowledge of ICH-GCP and regulatory requirements.

Responsabilidades

• Conduct on-site and remote monitoring visits to assess protocol compliance and patient safety.
• Verify source data against CRFs and ensure data integrity.
• Manage multiple clinical trial sites and maintain investigator relationships.
• Ensure compliance with GCP, ICH, and local regulations.

Conhecimentos

Analytical thinking

Communication skills

Time management

Formação académica

Bachelor's degree in life science/nursing or related field

Master's degree (advantage)

Ferramentas

CTMS

EDC systems

Descrição da oferta de emprego

About the Role

Our client, a globally recognized pharmaceutical company, is seeking an experienced Senior Clinical Research Associate (CRA) to join their dedicated clinical operations team in Durban. This crucial role involves overseeing and managing Phase III clinical trials, ensuring compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and study protocols. You will be responsible for site monitoring, data verification, and ensuring the safety and well-being of trial participants. This is an excellent opportunity to contribute to the successful execution of pivotal trials that can significantly impact patient care. The role requires a proactive individual with a keen eye for detail and a strong understanding of clinical trial processes. Located in the coastal city of Durban, KwaZulu-Natal, this position offers a chance to be part of groundbreaking medical research.

Key Responsibilities

• Conduct on-site and remote monitoring visits to clinical trial sites to assess protocol compliance, data accuracy, and patient safety.
• Verify source data against case report forms (CRFs) and ensure data integrity.
• Manage assigned clinical trial sites, fostering strong relationships with investigators and site staff.
• Ensure all study-related activities and documentation are in compliance with GCP, ICH guidelines, and local regulations.
• Identify, evaluate, and implement corrective and preventive actions (CAPAs) for site-specific issues.
• Prepare monitoring visit reports and communicate findings and action items to study teams and site personnel.
• Oversee the qualification, training, and ongoing support of clinical trial site staff.
• Manage study supplies and drug accountability at investigational sites.
• Contribute to the development of study protocols, informed consent forms, and other essential trial documents.
• Ensure timely resolution of data queries and site-level issues.

Requirements

• Bachelor's degree in a life science, nursing, or related field. A Master's degree is an advantage.
• Minimum of 5 years of experience as a Clinical Research Associate, with significant experience in Phase III trials.
• In-depth knowledge of ICH-GCP guidelines and relevant regulatory requirements.
• Proven ability to conduct effective site monitoring visits and manage multiple clinical trial sites simultaneously.
• Excellent understanding of clinical trial processes, including drug development, study design, and data management.
• Strong analytical and problem‑solving skills with meticulous attention to detail.
• Exceptional organizational and time management abilities.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Excellent written and verbal communication skills, with the ability to build rapport with healthcare professionals.
• Ability to travel to clinical trial sites as required.

Benefits

• Our client offers a competitive salary and bonus structure, reflecting the importance of this role.
• Comprehensive health insurance, including medical, dental, and vision coverage, is provided.
• A generous retirement savings plan and life insurance are also included.
• Opportunities for professional development are significant, with access to industry conferences, training programs, and continuing education support.
• The company promotes a positive work-life balance and offers a supportive team environment.
• This role provides the chance to work on critical clinical trials impacting public health, based in the vibrant city of Durban.