About the Role Our client, a leading innovator in the pharmaceutical industry, is seeking a highly skilled and motivated Senior Clinical Research Associate (CRA) to join their dynamic team in Johannesburg. This pivotal role involves overseeing and managing clinical trials, ensuring compliance with regulatory standards and protocols, and contributing to the development of groundbreaking medications. The ideal candidate will possess a deep understanding of clinical trial processes, excellent communication skills, and a passion for advancing healthcare. This position offers a unique opportunity to work on cutting-edge research and development projects within a supportive and collaborative environment, directly impacting patient lives. We are committed to fostering professional growth and providing resources for continuous learning and development within the pharmaceutical sciences. The Johannesburg location offers a vibrant urban experience with access to world-class facilities and a diverse talent pool, making it an ideal place to build a fulfilling career. Our client prides itself on a culture of scientific excellence and ethical practice, ensuring every team member contributes to meaningful advancements.
Key Responsibilities
- Conduct site initiation, monitoring, and close-out visits to ensure adherence to study protocols, GCP, and regulatory requirements.
- Manage multiple clinical trial sites, acting as the primary liaison between the sponsor and investigators.
- Collect, review, and verify data for accuracy, completeness, and integrity, addressing any discrepancies promptly.
- Ensure all trial-related documentation is maintained in accordance with regulatory standards and company SOPs.
- Train and mentor junior CRAs and site staff on study procedures and requirements.
- Oversee the informed consent process and patient safety at study sites.
- Prepare and present regular reports on site performance and trial progress to project management.
- Identify and mitigate potential risks to trial timelines and data quality.
- Ensure the timely procurement and dispensing of investigational products at assigned sites.
- Participate in the development and review of clinical trial protocols and other study documents.
Requirements
- Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
- Minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical industry.
- In-depth knowledge of ICH-Good Clinical Practice (GCP) guidelines and relevant regulatory requirements (e.g., FDA, EMA).
- Proven experience in monitoring clinical trials across various therapeutic areas.
- Excellent understanding of medical terminology and clinical trial processes.
- Proficiency in using electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Strong organizational, problem-solving, and analytical skills.
- Exceptional written and verbal communication abilities, with fluency in English.
- Ability to travel as required to assigned clinical trial sites.
- Demonstrated ability to work independently and collaboratively within a team setting.
Benefits
- Our client offers a comprehensive benefits package designed to support the well‑being and professional development of its employees. This includes competitive salary, performance-based bonuses, extensive health and dental insurance coverage, and a generous retirement savings plan.
- Employees also benefit from ongoing professional development opportunities, including training programs, conference attendance, and support for further education.
- We provide a flexible working environment with opportunities for remote and hybrid work arrangements, along with paid time off, sick leave, and parental leave policies.
- Additionally, employees have access to wellness programs, employee assistance programs, and a vibrant company culture that encourages innovation and collaboration.
- The Johannesburg office is well-equipped with modern amenities to ensure a productive and comfortable work experience.