Pharmaceutical Clinical Research Associate (CRA)

Placements24; Paarl; Ibrido; ZAR 600.000 - 900.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work model

Health insurance

Retirement plan

Professional development

Descrizione del lavoro

Placements24 in Paarl seeks a Pharmaceutical Clinical Research Associate to monitor and support clinical trials, ensuring data integrity and patient safety. This hybrid role blends field monitoring with office duties.

The position requires 3+ years of CRA experience, a Life Sciences related degree, GCP knowledge, and proficiency with CTMS/EDC systems.

Competenze

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field is required.
• Minimum of 3 years of CRA or related clinical research experience.
• Strong understanding of GCP and regulatory guidelines.
• Excellent monitoring, data integrity, and site management skills.
• Proficient in CTMS and electronic data capture systems.

Mansioni

• Monitor clinical trial sites to ensure compliance with study protocols, SOPs, and regulatory guidelines (GCP, ICH).
• Conduct site initiation visits, routine monitoring visits, and close-out visits.
• Verify accuracy, completeness, and validity of trial data.
• Manage essential study documents and regulatory files.
• Liaise between sites, sponsor, and internal study teams; address issues and ensure patient safety.

Conoscenze

Attention to detail

Communication

GCP knowledge

Monitoring

Formazione

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

Strumenti

CTMS

EDC systems

Descrizione del lavoro

About the Role

Our client, a global leader in pharmaceutical research and development, is seeking a meticulous and dedicated Pharmaceutical Clinical Research Associate (CRA) to join their team in the Paarl region. This critical role ensures the successful execution and monitoring of clinical trials in accordance with study protocols, GCP, and regulatory requirements. You will be responsible for site management, data integrity, and patient safety, playing a vital part in bringing new medicines to market. This hybrid position offers a blend of field visits and office-based responsibilities, allowing for effective oversight of clinical trial sites.

Key Responsibilities

• Monitor clinical trial sites to ensure compliance with study protocols, SOPs, and regulatory guidelines (GCP, ICH).
• Conduct site initiation visits, routine monitoring visits, and close-out visits.
• Verify the accuracy, completeness, and validity of clinical trial data.
• Manage and maintain essential study documents and regulatory files.
• Act as a liaison between the investigative sites, sponsor, and internal study teams.
• Address site issues promptly and ensure patient safety throughout the trial duration.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• Minimum of 3 years of experience as a Clinical Research Associate (CRA) or in a related clinical research role.
• Strong understanding of Good Clinical Practice (GCP) and relevant regulatory guidelines.
• Excellent monitoring skills, attention to detail, and ability to manage multiple sites.
• Effective communication, interpersonal, and problem-solving skills.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.

Benefits

• Competitive salary and potential for performance-based bonuses.
• Hybrid work model offering flexibility for site visits and remote work.
• Comprehensive health, dental, and vision insurance coverage.
• Retirement savings plan with employer contributions.
• Opportunities for professional development and career growth within clinical research.