Clinical Research Associate II 

Typical Accountabilities

• Drive performance at the sites. Perform site monitoring and other onsite visit activities according to monitoring plan and in compliance with AZ procedural documents . Provide the required monitoring visit reports within required timelines. Proactively identify study-related issues and escalates to Local Study Teams as appropriate. 

• Contribute to the selection of potential investigators. Train, support and advise Investigators and site staff in study related matters. 

• Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents and local regulations. Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites. 

• Perform source data verification according to SDV plan. Ensure data query resolution. Work with data management to ensure quality of the study data. 

• Ensure accurate and timely reporting of Serious Adverse Events. 

• Share relevant information on patient recruitment and study site progress within local Study Team. Update VCV and other systems with data from centers as per required timelines 

• Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA. 

• Adherence to AstraZeneca’s Code of Conduct and company policies and procedures.

Education, Qualifications, Skills and Experience

Essential

• Bachelor degree in biological science or healthcare-related field, or equivalent 

• Minimum 2-year experience as CRA or other related fields. Experience as a clinical monitor, performed all tasks for a CRA position.

• Knowledge of the Monitoring Process, such as understanding of the Study Drug Handling Process and the Data Management Process, etc. 

• Understanding of the clinical dataflow

• Solid knowledge of the clinical study and drug development processes, GCP/ICH guidelines and relevant local regulations

• Good computer skills in Microsoft and other software.

• Fluent in both oral and written English.

• Proficient written and verbal communication skills, collaboration and interpersonal skills.

Desirable

• Proactively identifies risks and issues and possible solutions

• Develops knowledge of therapy area through experience and review of scientific literature, and demonstrates ability to learn new therapy areas

• Demonstrates ability to prepare and deliver study related training materials

• Ability to coordinate work in a cross-functional international team environment, with certain level of influence and negotiation skills.

• Analysis on the current clinical trial and site monitoring situation, able to think of the improvement areas and solutions.