Clinical Research Associate - Oncology
Clinical Research Associate - ONCOLOGY
Competitive salary and benefits
At AstraZeneca (AZ) we are guided in our work by a strong set of values, and we are re-establishing the expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring teams together to deliver exceptional performance. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world as we develop our mission to turn ideas into life-changing medicines that transform lives.
Site Management and Monitoring (SM&M) is a part of Clinical Operations in the Development Operations function and executes and delivers clinical studies (mainly phase II – III) across the UK.
As a Clinical Research Associate (CRA)/Clinical Monitor you will have local responsibility for the delivery of the studies at allocated sites and will be an active participant in the local study team(s). You will work in close collaboration with other Monitors and the Local Study Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. You will be the main contact with the study site and will have responsibility for proper conduct of the study.
The CRA is responsible for the preparation, initiation, monitoring and closure of an agreed number of centres in clinical studies according to AZ Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations and that the centres deliver according to the commitment in the individual trials.
A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Local Study Manager.
You will obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents and local regulations both in the eTMF and Investigator Site File (ISF) in a timeline manner to keep the eTMF “inspection Ready” throughout the study.
Actively participate in local Study Team meetings.
Contribute to the selection of potential investigators.
Train, support and advise Investigators and site staff in study related matters, including Risk Based Quality Management principles.
Confirms that site staff have completed the required trainings and have documented them appropriately, including GCP training, during the duration of the study.
You will contribute to national Investigators meetings.
Education, Qualifications, Skills and Experience
- University degree in related discipline, preferably in life science, or equivalent qualification.
- Fluent knowledge of spoken and written English.
- Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
- Experience of monitoring Oncology clinical studies
- Good knowledge of relevant local regulations.
- Good medical knowledge in Oncology
- Basic understanding of the drug development process.
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
- Ability to travel nationally/internationally as required.
- Valid driving license
Open date: 22nd January 2021
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.