Clinical Research Associate SMM - Onco - HCM
Clinical Research Associate SMM - HCM
The ideal candidate is a passionate, self-motivated, and detail-oriented team player who is committed to the success of our customers. Then AstraZeneca might be the one for you!
About AstraZeneca and AstraZeneca Vietnam
AstraZeneca is a global, science-led biopharmaceutical company with a British-Swedish heritage that focuses on the discovery, development, and commercialization of prescription medicines. At AstraZeneca, science and patients are at the heart of everything we do. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
Established in 1994, AstraZeneca Vietnam has come a long way in 27 years of advancing Vietnam's healthcare. We change lives through innovative science with $25mil in R&D investment (2020 - 2024); 40 ongoing clinical trials with 2800+ patients; 44 partnered hospitals and 14 medicines involved in trials. We have built strong public-private partnerships for sustainability and healthcare access through many programs and activities such as Healthy Lung, Young Health Program, Careme, Giá Như, Health System Sustainability & Resilience, Green Energy for Health, Response to Covid-19.
We have gained some recognition for our efforts from the Minister of Health's Certificates of Merits for outstanding contributions to advancing cancer treatment (2019) and exceptional contributions to Vietnam’s fight against COVID-19 (2020); BritCham 2021 Awards for Contributions to healthcare and 25+ years of service in Vietnam; Ho Chi Minh Communist Youth Union’s Medal and Certificate of Merit for contributions to youths (2021); Excellent Leadership – Visionary Leader Award (2021); HR Excellence – Workplace Culture Award (2021) and Vietnam's Top 100 Places to Work Award (2018 - 2020).
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 Manager 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.
A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Local Study Manager.
- Contributes to the selection of potential investigators.
- In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
- Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
- Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
- Actively participates in Local Study Team (LST) meetings.
- Contributes to National Investigators meetings, as applicable.
- Initiates, monitors and closes study sites in compliance with AZ Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
- Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
- Updates CTMS and other systems with data from study sites as per required timelines.
- Manages study supplies (ISF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
- Performs 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 LSM the correct timing and type of visits.
- Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
- Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
- Ensures data query resolution in a timely manner.
- Works with data management to ensure robust quality of the collected study data.
- Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
- Prepares and finalises monitoring visit reports in CTMS and provides timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ SOP.
- Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
- Follows 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.
- Assists site in maintaining inspection ready ISF.
- Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSM and CQM.
- Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements. Supports/participates in regular QC checks performed by LSM or delegate.
- Ensures that all study documents under their responsibility (i.e. site documents, relevant communications, etc) are available and ready for final archiving and completion of local part of the eTMF.
- Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
- Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
- Ensures compliance with local, national and regional legislation, as applicable.
- Collaborates with local MSLs as directed by LSM or line manager.
At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and fuel 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 is always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.
What will you get?
We provide driven packages and benefits for proficient and qualified candidates; a winning dream team and colleagues who share ONE values, ideas, and goals.
So, what’s next?
If you are already inspiring yourself to join our dream team, we can’t wait to hear from you.
If you are ready to bring new insights and fresh thinking to the table, Brilliant! We have one seat available, and we hope it’s yours.
If you’re curious to know more then please take initiative to recruitment.Vietnam@astrazeneca.com. We encourage your application.
Where can I find out more?
Visit our website www.astrazeneca.vn
Follow us on LinkedIn www.linkedin.com/company/astrazeneca/
Contact us via recruitment.Vietnam@astrazeneca.com