10. CRA [AI ÇコÄÉ¾î ½ºÅ¸Æ®¾÷]
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cra | ¡¤ Independently generate, write, and edit study protocols, informed consents, case report forms, study reports, monitoring plans, and other clinical and regulatory documents. ¡¤ Manage pre- and post-market clinical studies from initiation to closure, ensuring compliance with industry standards, best practices, and study protocols. ¡¤ Maintain the trial master file and oversee study-related documentation, including medical images. ¡¤ Prepare for and conduct investigators` meetings, fostering effective communication and collaboration. ¡¤ Resolve discrepancies and address issues promptly, working closely with site personnel. ¡¤ Directly contribute to study recruitment and informed consent procedures. |
[ÀÚ°Ý¿ä°Ç] ¡¤ PhD, PharmD, RN or equivalent; BA/BS degree with relevant healthcare background may be considered. ¡¤ Minimum 2 years of independent clinical trial management in Korea, preferably in medical devices. ¡¤ Thorough understanding of medical device clinical trial design, MFDS regulations and other applicable industry standards. ¡¤ Proficiency in medical terminology related to cardiology, nephrology, and ophthalmology desired. ¡¤ Strong written and oral communication skills in both English and Korean. ¡¤ Ability to build and maintain effective relationships with trial center colleagues and staff. ¡¤ Excellent time management and prioritization abilities, with a keen attention to detail. ¡¤ Willingness to travel domestically as required. |
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