[Typical Accountabilities]
Contributes to the selection of potential investigators. 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.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.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.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 LSAD 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.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.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.Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and CQAD.Ensures timely collection/uploading of essential documents into the e TMF in accordance with ICH-GCP, AZ SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.Ensures compliance with Astra Zeneca’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. [Competencies and Skills]
Ability to deliver quality according to the requested standards. Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills. Good analytical and problem solving skills. Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. Team oriented and flexible; ability to respond quickly to shifting demands and opportunities[Qualifications]
신규/경력 CRA 1년 이상의 항암 임상시험 모니터링 경력 우대경력이 없는 경우, CRA 관련 교육 이수 시 지원 가능※ 채용 절차법에 따른 고지 사항
1. 전자우편으로 제출한 서류는 채용 절차법에 따라, 일체 반환 의무가 없습니다.
2. 보훈대상자 및 취업보호대상자는 관련법에 의거하여 우대합니다.
3. 해외 여행 결격사유가 없어야 합니다.
4. 본 채용은 수시진행으로, 우수인력 채용 시 마감될 수 있습니다.
Date Posted
05-2월-2025
Closing Date
