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Sr CRA in Multinational CRO Company(MNCs)
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[Company Status]
Multinational clinical drug development company(MNCs). Company is a global, contract research organization (CRO) employing about 2,200 professionals worldwide. At MNCs , you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in MNCs's impressive history of company stability and growth.We¡¯ve achieved these results by fostering a work environment that encourages, develops and leverages our team¡¯s capabilities. MNCs¡¯s ongoing success offers team members unsurpassed growth and career development opportunities. There¡¯s no better time to join us!
[Position] Sr CRA(Senior Clinical Research Associate)
[Job Functions]
¡¤Assist in managing large scale clinical trial projects or function as project manager for small scale projects, ensuring on-time, on-budget performance
¡¤Monitor (pre-study, initiation, routine, and close-out visits) investigator sites for GCP compliance according to PharmaNet SOPs and/or client guidelines
¡¤Recruit investigators
¡¤Negotiate study budgets with investigators
¡¤Obtain, review, and process regulatory and administrative documents from investigator sites
¡¤Review and develop protocols
¡¤Review and develop CRFs
¡¤Coordinate and present at Investigators¡¯ Meetings
¡¤Participate in proposal meetings with potential clients
¡¤Prepare and review Serious Adverse Event (SAE) reports
¡¤Prepare project management reports for clients, project personnel, and PharmaNet management
¡¤Resolve issues, questions, and requests for additional study supplies
¡¤Review and approve monitoring trip reports
¡¤Review and verify completed CRFs
¡¤Review clinical data in-house
¡¤Resolve queries of CRF data with study site personnel
¡¤Review Tables and Listings generated from study data
¡¤Author Clinical Study Reports
¡¤Train and mentor CRAs on monitoring, internal procedures, and query resolution
¡¤When allocated by study management, submit essential/required documents to a central IRB or a country¡¯s central Ethics Committee, and, if necessary based on local requirements, the Competent Authority
[Minimum Requirements]
¡¤Bachelor¡¯s Degree or nursing credential
¡¤Three and a half years¡¯ experience in clinical research, data management, or regulatory affairs
¡¤Twenty four months¡¯ field monitoring or equivalent experience
¡¤Ability and willingness to travel 50% of the time
¡¤Excellent organizational skills
¡¤Ability to manage time and work independently
¡¤Excellent written and oral communication skills
[Location] Seoul, Korea
[Salary]
- negotiation
- Full time job
[Number of Persons (Gender)] 1, No Gender preference
[Apply a Position]
Please send your English resume (Documents/ CVs must be written in English)A.S.A.P (MS word only)by E-mail top@topheadhunter.co.kr
* The title of E-mail should be Sr CRA in Multinational CRO Company.
* All submitted documents will be treated with highly confidential manner.
Thank you for your interest.
[Contact]
Tel No 82-2-555-7234
E-mail top@topheadhunter.co.kr
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