°æ·Â/ ½ÅÀÔ CRA (0¸í)
Job Position : °æ·Â/ ½ÅÀÔ CRA
Job Porpose : To perform activities in the preparation, initiation, monitoring and closure for an agreed number of centres
in all clinical studies according to AZ Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations. To ensure quality and quantity commitments are achieved in a timely manner.
KEY RESPONSIBILITIES (Key activities or measurements) * Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents and local regulations both in the office and at site. * Actively participate in internal and external meetings (e.g. Local Study Delivery Team meetings, country investigators meetings and so on). * Contribute to the selection of potential investigators. * Initiate, monitor and close study sites in compliance with AZ Procedural Documents. * Lead initiation, maintenance and closure of the study master file (SMF), investigator study file (ISF) in compliance with AZ Procedural Documents. * Share information on patient recruitment and study site progress within Local Study Delivery Team. * Update IMPACT with data from centres in a timely manner. * Manage study supplies at study site level. * Manage study drug supplies and accountability at the study sites. * Train, support and advise study personnel in study related matters. * Perform source data verification according to SDV plan. * Achieve the respective assignment according to timetable requirements. * Ensure accurate and timely reporting of Serious Adverse Events. * Ensure data query resolution. * Prepare for activities associated with audits and regulatory inspections in liaison with CQA. * Provide input into process development and improvements. * Track and manage agreed payments at study site level. * Keep track on research intelligence in local market. * Contribute to process improvements: work with other members of the organisation to share knowledge, experience and best practices. * Work with Data Management to ensure the quality of the study data
QUALIFICATIONS * At least 1 yr CRA experience required for permanent position
* Excellent knowledge of spoken and written English. * Good ability to learn and to adapt to work with IT systems.
Application & Contact Information (Áö¿ø¹æ¹ý)1) Á¦Ãâ¼·ù: À̷¼(ÀÚ±â¼Ò°³¼) -> MS word ÆÄÀÏ
(ÁÖ)µ¥Àϸ®¸Þµð 100-450 ¼¿ï½Ã Áß±¸ ´Ù»ê·Î 162 (½Å´çµ¿340-73) ¾à¼öºôµù 5Ãþ»ç¾÷ÀÚµî·Ï¹øÈ£:114-86-23062 µî·Ï¿¬¿ùÀÏ : 2007.7.10ÀÏ ´ëÇ¥ : ¾È¼ø¹ü
ÀüȹøÈ£ : 02-927-8955~7 /8981 Æѽº¹øÈ£ :02-2231-9275 À̸ÞÀÏ:jhj@dailymedi.com