Clinical Research Associate
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
What you will do?
As a Clinical Research Associate you will be 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.
Main responsibilities include :
You will actively participate in Local Study Team (LST) meetings and contributes to National Investigators meetings, as applicable.
Act as an initiator and monitor and close study sites in compliance with AZ Procedural Documents. Share information on patient recruitment and study site progress (site quality/performance) within the LST.
Driving performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
Responsible for management of study supplies (ISF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
You will perform monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits.
Ensuring data query resolution in a timely manner and work with data management to ensure robust quality of the collected study data.
Ensuring accurate and timely reporting of Serious Adverse Events and their follow ups.
Preparing and finalizing monitoring visit reports in CTMS and provides timely feed-back to the Principal Investigator.
Following quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required.
Preparing and collaborating for activities associated with audits and regulatory inspections in liaison with LSAD and CQAD.
Ensuring that all study documents under their responsibility are available and ready for final archiving and completion of local part of the eTMF.
Providing feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
Essential skills required:
1-2 years of experience with similar role
Verbal and written communication skills
Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification.
Knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
Good knowledge of relevant local regulations.
Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
Basic understanding of the drug development process.
Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
Excellent attention to details.
Good written and verbal communication skills.
Good collaboration and interpersonal skills.
Good negotiation skills.
Fluent in English
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what’s next!
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn: https://www.linkedin.com/company/1603/
Inclusion & Diversity: https://careers.astrazeneca.com/inclusion-diversity
Career Site: https://careers.astrazeneca.com/
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.
