Novo Nordisk — семіздік пен диабетті емдеуге арналған препараттарды әзірлеуге бағытталған жаһандық денсаулық сақтау компаниясы. Компания бұл салаларда 25 жылдан астам уақыт бойы зерттеу жүргізіп келеді. 1923 жылы құрылған компания өмірдің әртүрлі кезеңдеріндегі пациенттерді қолдауға арналған дәрі-дәрмектер өндіреді және жалған дәрілермен күресу шараларын қоса алғанда, өнімдерінің қауіпсіздігі мен тұтастығын нығайтуға жұмыс істейді. Оның қызметі фармацевтикалық зерттеулерді, пациенттерге күтім көрсетуді және негізгі емдеу әдістеріне қолжетімділікті жақсартуға бағытталған ауқымды бастамаларды қамтиды.
Junior Clinical Research Associate
Monitor clinical trial sites for Novo Nordisk in South Africa, supporting participant safety, reliable data and study quality. Apply risk-based monitoring across on-site and remote visits.
Сипаттама
- Monitor assigned clinical trial sites through on-site and remote visits using risk-based quality management.
- Serve as the primary contact among Novo Nordisk, clinical sites and the study team.
- Conduct monitoring visits in line with the monitoring plan, protocol, ICH-GCP, SOPs and local regulations.
- Safeguard participant safety and data integrity by reviewing site data, resolving discrepancies and managing adverse events.
- Keep data cleaning on schedule.
- Monitor recruitment, retention, data collection and site performance against study timelines, quality goals and clinical operations KPIs.
- Train and assist site staff with protocols, procedures and systems.
- Oversee investigational products, study supplies, equipment and essential records, including the Investigator Trial Master File.
- Maintain inspection-ready trials and assist with audits and inspections.
- Address site issues promptly or escalate them when needed.
- Provide site feedback and suggest practical improvements.
- Share knowledge with and support fellow CRAs.
- Report to the Clinical Operations Manager.
- Take part in investigator meetings, CRA training and local and global trial meetings.
Талаптар
- Bachelor’s degree in life sciences or a related discipline.
- Basic Good Clinical Practice (GCP) qualification.
- At least two years of industry-sponsored clinical research experience, or up to one year of experience as a CRA.
- Sound understanding of ICH-GCP, regulatory requirements and clinical trial methods.
- Confidence with clinical trial platforms such as electronic data capture (EDC), CTMS and eTMF.
- Strong planning and time management skills.
- Careful attention to detail when handling multiple sites and priorities.
- Clear written and spoken communication.
- Ability to build trusted working relationships with site staff and colleagues at all levels.
- Proactive approach to solving problems.
- Willingness to travel as needed.
Артықшылықтар
- Opportunity to grow on the job and develop monitoring expertise.
- Learn alongside experienced CRAs, the manager and the wider trial team.
- CRA training.
- Access to international study meetings.
- Participation in investigator meetings.
- Inclusive recruitment and equal opportunity.