Clinical Research Associate II  (FSP)

Typical Accountabilities

• Drive performance at the monitoringand other onsite visit activitiesaccording to monitoring planand in compliance with AZ proceduraldocuments.Provide the required monitoring visit reports within required timelines. Proactivelyidentifystudy-related issues and escalatesto Local Study Teamsasappropriate.

• Contribute to theselectionof potential support andadviseInvestigators and site staff in study related matters.

• Obtain andmaintainessential documentation in compliance with ICH-GCP AZ Procedural Documents and study supplies (ISF CRF etc) drug supplies and drug accountability at study sites.

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

• Ensureaccurateandtimelyreporting of Serious Adverse Events.

• Sharerelevantinformation on patient recruitment and study site progress within local Study 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.

• AdherencetoAstraZenecas Code of Conduct and company policies and procedures.

Education QualificationsSkillsand Experience

Essential

• Bachelordegree in biological science or healthcare-related field or equivalent

• Minimum 2-year experienceasCRA or other related 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

• Solidknowledge of the clinical study and drug development processes GCP/ICHguidelinesand relevant local regulations

• Good computer skills in Microsoft and other software.

• Fluent in both oral and written English.

• Proficient written and verbal communication skillscollaborationand interpersonal skills.

Desirable

• Proactivelyidentifiesrisks and issues andpossible solutions

• Develops knowledge of therapy area through experience and review of scientific literature anddemonstratesability 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.