Senior Clinical Research Associate (Gauteng)

Placements24; Benoni; Presencial; ZAR 900.000 - 1.200.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Retirement savings plan

Paid time off

Descripción de la vacante

Placements24 in Benoni, Gauteng, seeks a Senior Clinical Research Associate to oversee trials across investigative sites. You will ensure GCP compliance, monitor sites, and manage data integrity while coordinating with investigators.

The role requires a life-science degree and at least five years' CRA experience, with travel to sites around Gauteng. A proactive, independent, and collaborative approach is essential to advancing clinical research.

Formación

• Deep understanding of GCP guidelines and regulatory requirements.
• Experience conducting site initiation, monitoring and close-out visits.
• Proven ability to manage multiple trials and sites.
• Strong data quality and documentation skills.

Responsabilidades

• Develop and implement trial protocols per regulatory standards.
• Conduct site initiation, monitoring and close-out visits.
• Oversee patient recruitment and adherence to criteria.
• Maintain study documentation and product accountability.
• Liaise with investigators and site staff to resolve issues.
• Ensure timely data collection and query resolution.

Conocimientos

GCP knowledge

Clinical trial monitoring

Site management

Regulatory compliance

Data integrity

Educación

Bachelor's degree in life science, nursing, pharmacy, or related field

Herramientas

EDC systems

CTMS

Microsoft Office

Descripción del empleo

About the Role Our client, a leading entity in the pharmaceutical sector, is seeking a highly experienced and motivated Senior Clinical Research Associate (CRA) to join their dynamic team. This role is crucial for overseeing and managing clinical trials at various investigative sites across **Benoni, Gauteng**. The ideal candidate will possess a deep understanding of Good Clinical Practice (GCP) guidelines and regulatory requirements, ensuring the integrity and quality of data collected. This is an exceptional opportunity to contribute to groundbreaking research and development within the pharmaceutical industry, working with a company committed to innovation and patient well-being. You will play a pivotal role in advancing new therapies from development to market, ensuring compliance and operational excellence at every stage. The position requires a proactive approach to site management and a strong commitment to ethical research practices. We are looking for a self-starter who can work independently and as part of a collaborative team.

Key Responsibilities

• Develop and implement clinical trial protocols in accordance with regulatory standards and company policies.
• Conduct site initiation, monitoring, and close-out visits to ensure compliance with protocols, GCP, and regulatory requirements.
• Oversee patient recruitment and enrollment, ensuring adherence to inclusion/exclusion criteria.
• Manage and maintain accurate study documentation, including investigational product accountability and source document verification.
• Liaise effectively with investigators, study coordinators, and site staff to address any study-related issues promptly.
• Ensure timely collection, query resolution, and accuracy of clinical data.
• Prepare and present study progress reports to project management and stakeholders.
• Identify and mitigate potential risks and challenges at investigative sites.
• Facilitate regulatory inspections and audits at study sites.
• Contribute to the development of study-related documents, including case report forms (CRFs) and informed consent forms.

Requirements

• Bachelor's degree in a life science, nursing, pharmacy, or related field; advanced degree preferred.
• Minimum of 5 years of progressive experience as a Clinical Research Associate in the pharmaceutical industry.
• Proven track record of successful site management and monitoring across multiple clinical trials.
• In-depth knowledge of ICH-GCP guidelines, FDA regulations, and other relevant regulatory requirements.
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Excellent communication, interpersonal, and organizational skills.
• Ability to travel to investigative sites within **Benoni, Gauteng** and surrounding areas as needed (approximately 60-70% travel).
• Strong problem-solving abilities and a proactive approach to identifying and resolving issues.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Demonstrated ability to work independently and manage multiple priorities effectively.

Benefits

• Our client offers a competitive salary package commensurate with experience, along with comprehensive benefits. This includes health insurance, a retirement savings plan, and paid time off.
• Opportunities for professional development and continuous learning are strongly encouraged, including access to internal and external training programs.
• You will be part of a supportive and collaborative work environment where your contributions are valued and recognized.
• This role offers the chance to work on cutting-edge pharmaceutical research and make a tangible impact on global health outcomes.

Join a team dedicated to scientific advancement and ethical research in the vibrant province of **Gauteng**.