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 (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. AstraZeneca Vietnam 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. 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. What you’ll 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. Trains, supports and advises Investigators and site staff in study related matters. Confirms that site staff have completed and documented the required trainings appropriately. 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. Drives performance at the sites. Updates CTMS and other systems with data from study sites as per required timelines. Manages study supplies and drug accountability at study site. Performs monitoring visits (remote and onsite). Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV). Performs regular Site Quality Risk Assessments. 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. Prepares and finalises monitoring visit reports in CTMS. Follows up on outstanding actions with study sites. Follows quality issue processes by escalating systematic or serious quality issues. Assists site in maintaining inspection ready ISF. Prepares for and collaborates with the activities associated with audits and regulatory inspections. Ensures timely collection/uploading of essential documents into the eTMF. Ensures that all study documents under their responsibility are available and ready for final archiving. Provides feedback on any research related information. Ensures compliance with AstraZeneca’s Code of Ethics and local regulations. Collaborates with local MSLs as directed. Essential Skills/Experience: Bachelors degree in related discipline, preferably in life science, or equivalent qualification. Excellent knowledge of international guidelines ICH-GCP. 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. 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. Ability to look for and champion more efficient methods of delivering quality clinical trials. Good analytical and problem-solving skills. Demonstrates ability to prioritize and manage multiple tasks. Familiar with risk-based monitoring approach. Good cultural awareness. So, what’s next? Are you ready to make a difference? Apply now to join our team! Where can I find out more? Visit our website www.astrazeneca.vn Follow us on LinkedIn www.linkedin.com/company/astrazeneca/ and Facebook https://www.facebook.com/AstraZenecaVN Contact us via recruitment.Vietnam@astrazeneca.com #J-18808-Ljbffr