\uc0ac\uc774\ud2b8:<\/p>\n
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https:\/\/astrazeneca.wd3.myworkdayjobs.com\/Careers\/job\/South-Korea—Seoul\/Clinical-Research-Associate_R-127112?source=Linkedin<\/p>\n
<\/p>\n
Typical Accountabilities:<\/p>\n
\tContributes to the selection of potential investigators.
\n \tIn 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.
\n \tTrains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
\n \tConfirms 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.
\n \tActively participates in Local Study Team (LST) meetings.
\n \tContributes to National Investigators meetings, as applicable.
\n \tInitiates, 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.
\n \tDrives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
\n \tUpdates CTMS and other systems with data from study sites as per required timelines.
\n \tManages study supplies (ISF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
\n \tPerforms 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.
\n \tPerforms Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
\n \tPerforms regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
\n \tEnsures data query resolution in a timely manner.
\n \tWorks with data management to ensure robust quality of the collected study data.
\n \tEnsures accurate and timely reporting of Serious Adverse Events and their follow ups.
\n \tPrepares 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.
\n \tFollows up on outstanding actions with study sites to ensure resolution in a timely manner.
\n \tFollows 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.
\n \tAssists site in maintaining inspection ready ISF.
\n \tPrepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSM and CQM.
\n \tEnsures 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.
\n \tEnsures 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.
\n \tProvides feedback on any research related information including sites\/investigators\/competing studies that might be useful for the local market.
\n \tEnsures compliance with AstraZeneca\u2019s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
\n \tEnsures compliance with local, national and regional legislation, as applicable.
\n \tCollaborates with local MSLs as directed by LSM or line manager.<\/p>\n
Competencies and Skills:<\/p>\n
\tAbility to deliver quality according to the requested standards.
\n \tAbility to work in an environment of remote collaborators.
\n \tManages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
\n \tAbility to look for and champion more efficient and effective methods\/processes of delivering quality clinical trials with reduced budget and in less time.
\n \tExcellent written and verbal communication skills, negotiation, collaboration and interpersonal skills.
\n \tGood analytical and problem solving skills.
\n \tDemonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
\n \tGood cultural awareness.
\n \tAbility 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.
\n \tTeam oriented and flexible; ability to respond quickly to shifting demands and opportunities.<\/p>\n
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\uc0ac\uc774\ud2b8: https:\/\/astrazeneca.wd3.myworkdayjobs.com\/Careers\/job\/South-Korea—Seoul\/Clinical-Research-Associate_R-127112?source=Linkedin 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 […]<\/p>\n","protected":false},"author":9113,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[6],"tags":[],"class_list":["post-7955","post","type-post","status-publish","format-standard","hentry","category-free-board"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.syu.ac.kr\/pharmacy\/wp-json\/wp\/v2\/posts\/7955","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.syu.ac.kr\/pharmacy\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.syu.ac.kr\/pharmacy\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.syu.ac.kr\/pharmacy\/wp-json\/wp\/v2\/users\/9113"}],"replies":[{"embeddable":true,"href":"https:\/\/www.syu.ac.kr\/pharmacy\/wp-json\/wp\/v2\/comments?post=7955"}],"version-history":[{"count":0,"href":"https:\/\/www.syu.ac.kr\/pharmacy\/wp-json\/wp\/v2\/posts\/7955\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.syu.ac.kr\/pharmacy\/wp-json\/wp\/v2\/media?parent=7955"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.syu.ac.kr\/pharmacy\/wp-json\/wp\/v2\/categories?post=7955"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.syu.ac.kr\/pharmacy\/wp-json\/wp\/v2\/tags?post=7955"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}