Clinical Research Associate - Oncology - Hanoi

Clinical Research Associate - Oncology - HN

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

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global science-led biopharmaceutical company that focuses on the discovery development and commercialization of prescription medicines in Oncology Rare Diseases and BioPharmaceuticals including Cardiovascular Renal & Metabolism and Respiratory & Immunology. Based in Cambridge UK AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit and follow the Company on Twitter @AstraZeneca.

AstraZeneca Vietnam

As a Foreign Invested Enterprise with over 600 members AstraZeneca is investing into Vietnam 360 million USD from 2020 to 2030 with a focus on reducing the burdens of non-communicable diseases developing local talent and uplifting the domestic biopharmaceutical R&D and manufacturing capabilities.

Over the last three decades accompanying Vietnams sustainable development AstraZeneca has run several impactful programmes in collaboration with the Government Ministry of Health and healthcare partners to promote disease awareness prevention and early recent years AstraZeneca Vietnam has received several certificates of merit from the Prime Minister and Minister of Health for excellent contributions to Vietnams vaccine diplomacy fight against COVID-19 and advancement of cancer treatment and disease awareness. The company has also been recognized among Vietnams Top 100 Best Places to Work () with various other industry awards from BritCham EuroCham and government agencies.

Introduction to Role:
Join us as a Clinical Research Associate in our Oncology team where you will have local responsibility for the delivery of studies at allocated sites. You will be an active participant in the local study team(s) working 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. This role offers an opportunity to learn and grow from the brightest minds in the industry making it an ideal platform for those seeking to build meaningful careers.

What youll do

Typical accountabilities:

• 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 AstraZenecas 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.

Essential Skills/Experience:
- Bachelors degree in related discipline preferably in life science or equivalent qualification.
- Excellent 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.
- Ability to travel nationally/internationally as required.
- Valid driving license.

Desirable Skills/Experience:
- Ability to work in an environment of remote collaborators.
- Manages change with a positive approach for self team and the business.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
- Good analytical and problem-solving skills.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Familiar with risk-based monitoring approach including remote monitoring.
- Good cultural awareness.

Be bold and make a powerful impact: AstraZeneca is a world-leading business where standards are high and challenges complex but also a collective where we build support and motivate each other. This unique combination of strong expectation and empowerment invites you to improve how our markets work and make your individual mark. Here you can follow your ambitions with full confidence. As part of a responsible value-led business with a strong sustainability agenda you can also help impact the future beyond business projects.

Be part of our growth journey and success story: Join the fastest growing pharmaceutical company in our markets set up to fuel further growth. Make the most of our assets: our strong heritage our early investment and commitment in emerging markets and how we embrace digital and data to transform the patient journey. Go beyond your limits. Welcome failure as a chance to learn. Theres no better place to feel inspired energised and try new things.

Learn and grow by embracing diverse opportunities: Experience an organisation where professional development is prized and nurtured. Access the tools and support you need to continuously learn. Then its up to each of us to step up speak up and show what we can do. Take advantage of working in a global business with opportunities to move beyond your role and open international doors. At AstraZeneca your future is in your own hands.

Urgently bring our leading pipeline to millions of patients in need: Seize the opportunity to help improve the lives of millions of patients including in areas where patient needs are often unmet. Work with our transformative pipeline to help bring a variety of high-quality medicines to market and ensure they are made easily accessible to as many patients as possible.

Be heard in a culture of local empowerment: AstraZeneca is set up for creativity. We encourage unity and ownership at a local level with collaboration across the global organisation. We tailor how we work adapting to our markets and healthcare our diverse community every voice is important. Share your ideas and opinions our speak-up culture the way we communicate with each other leads to more powerful innovation.

So whats next

Are you ready to make a difference Apply now to join our team!

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Date Posted