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1. Æ÷Áö¼Ç: Senior. Clinical Research Associate2. °è¿»ç: Çѱ¹¾á¼¾ (Janssen) 3. ±Ù¹«Áö: ¼¿ï½Ã ¿ë»ê±¸4. ±Ù¹« ÇüÅÂ: Regular
[Summary]
A Senior. Clinical Research Associate (Site Manager II) in Early Development & Clinical Pharmacology (ED&CP) serves as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of complex early development and/or clinical pharmacology studies. A Site Manager II is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), Healthcare compliance (HCC) requirements, applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out. Partners with the Clinical Trial Assistant (CTA, Trial Manager (TM) and Global Trial leader (GTL) to ensure overall site management while performing trial related activities for assigned protocols.
A Site Manager II may contribute to process improvement, training and mentoring of other Site Managers.
[Responsibilities]
Principal Relationships:
Primary Reporting Structure: Reports to Functional Manager (FM).
Primary interfaces: FM, CTAs, TMs, SMs, PIPS, SIPS, Site Strategic Leads (SSLs), GTLs, Study Responsible Physicians (SRP), Quality & Compliance Manager/Specialist, Local Safety Officer
Other Internal Interfaces: Contract and Compliance Services (CCS), GPLs, TA representatives, Integrated Data Analytics and Reporting (IDAR), Bioresearch Quality and Compliance (BRQC), ED&CP Head/US ED&CP Head, ED&CP Business Operations & Quality Leader and others as required
External Interfaces: Investigational Site Staff and others as required
[Requirements]
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