Clinical Research Associate

Do you have expertise in, and passion for Clinical Studies? If so, AstraZeneca might be the one for you_

**ABOUT ASTRAZENECA**

AstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

**ABOUT OUR CLINICAL TEAM**

This unique achievement affords the opportunity for permanent resources to be sustained and thus ensures a significant local input into the global company’s R&D clinical trials. It also allows doctors and researchers in South Africa to be at the forefront of technology and innovation, to attend international meetings, and in some instances, to gain authorship of publications in highly credible journals. In addition, it allows capacity building within the country by exposing academic staff and new trialists to novel agents. South Africa has participated in many key AstraZeneca projects over all therapeutics areas and is experienced in conducting phase I-IV trials.

**What you’ll do?**

The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.

The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. Opportunities exist in both the Biopharma and Oncology disciplines.

Some areas of focus for this role will include:

- Ensures the processes for Study Delivery are executed through the development of study reports tools, facilitation of the study delivery system and maintenance of the system.
- As an expert, ensures delivery of a centrally managed study management service across clinical studies from start up to reporting.
- Serve as main contact and works closely with the Document Management group until the Clinical Study Report is finalized.
- Initiates and maintains production of study documents, ensuring template and version compliance.
- Creates or imports clinical-regulatory documents into the Global Electronic Library according to the Global Document List.
- Interfaces with Data Management Centre or Data Management Enablement representatives to facilitate the delivery of study related documents.
- Manages and coordinates tracking of study materials and equipment.
- Monitors administrative tasks during the study process, audits and regulatory inspections, according to company policies.
- Acts as a technical owner within Patient Safety with a deep understanding of processes and internal regulations.
- Keeps own knowledge of best practices and new relevant developments up to date.
- Liaises with compliance team members to improve regulatory processes within the team.
- Identifies opportunities to improve the methodology and provide practical solutions for clinical development.

**If this sounds appealing, please read on to understand the experience and skills we’re looking for**

**ESSENTIAL SKILLS & EXPERIENCE REQUIRED?**
- Bachelor’s degree in life sciences.
- Advanced degree within the field.
- Professional certification.
- Experience of Study Management within a pharmaceutical or clinical background.
- Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management.

**Why AstraZeneca?**
- At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare._
- Join the fastest growing pharmaceutical in our markets, set up to fuel further growth. Be part of our shared ambition and pride: our strong heritage, our turnaround story, and early investment and