*Job Description
The individual participates in the conduct of single and multi-center clinical research studies, presents at monitor training meetings and investigator meetings, monitors recruitment and overall study progress, addresses issues as they arise within the realm of the CRA position, and makes decisions with the guidance of the Clinical Research Manager (CRM). Responsible for preparing study update reports and graphs. o Participate in the planning of a study or multiple studies with the CRM. o Perform operation and administrative duties assigned by the CRM. o Assist with the CRO selection process and ensure contractual obligations are met. o Assist the CRM with site study budget negotiations and payments. o Assist CRM with Vendor identification and selection and payments vis a vis contractual agreements. Contribute to development of a payment schedule section for Vendors and process/obtain approval from management o Assist the CRM as a lead CRA to study start up, study execution and close out activities. o Assist in the development and coordination of protocols and informed consent forms. o Assist in the planning and coordinating investigation meetings. Prepare and present protocol and general study-related presentation to field monitors, investigations and adequately informed of protocol requirements, standard operating procedures and monitoring procedures. o Review data in the electronic data capture system; enter and reconcile queries as necessary. May also be involved in query resolution. Assist in trent review. o Participate in the development of site reference materials. o Monitor site preparation, including sending regulatory document packages to sites. o Assist the sites in obtaining the required forms and passwords for all electronic systems. o Prepare training materials related to monitoring practices and procedures to be presented at monitor training meetings to ensure that the monitors are adequately informed of monitoring requirements and procedures. o Review site qualification monitoring visit reports to assess site eligibility to participate in the study. o Review monitoring reports throughout the study to ensure that sites are adhering to the protocol and to identify potential issues and propose solutions. o Track and report on monitoring activities o Assist the CRM in CRO in vendor management, including independently holding meetings to identify and resolve issues. Maintain open lines of communication. o Monitor ongoing progress of enrollment and other benchmarks at the investigative sites to assess adherence to the study protocol and timelines o Maintain the internal tracking systems, including budgets and expenditures. o Mentor CRA¡¯s regarding regulatory accuracy and set-up of the Trial Master File o Perform operation and administrative duties assigned by the CRM. o Mentoring junior CRAs o Ensure that conduct of all studies follow local or global Ferring SOPs and regulatory requirements. *ÁÖ¿ä ¾÷¹«:1. CTA (Clinical Trial Associate) - ÀÓ»ó½ÃÇèÀÇ ¹®¼Á¤¸®, °ü¸® ¹× administration (°¢ ±â°üÀÇ ¿¬±¸ºñ ¹× °è¾à¼ °ü¸®, PO, PI) 2. Medical team administration – MA team¿¡¼ ÁøÇàÇÏ´Â Çà»çÀÇ Áغñ, º¸Á¶, ¿î¿µºñ Áö±Þ (e.g. PO, PI) ¹× °ü¸® (e.g. ABM, symposium, Preceptorship, in/ex meetings and etc.)
*¾÷¹«±â°£: 2019.10 – 2021.10 (ASAP/2³â)
*Job Requirements
*Required education: ±¹³»¿Ü 4³âÁ¦ ´ëÁ¹ÀÚ (»ý¸í°úÇÐ ¼±È£) *Qualification: CRO/Á¦¾à»çÀÇ ¸ð´ÏÅ͸µ¾÷¹« À¯ °æÇèÀÚ, CRC °æ·ÂÀÚµµ °¡´É, MS-office (Word, Excel, PPT) °¡´É, ¸Å»ç Àû±ØÀûÀÌ°í ÁøÃëÀûÀÎ ºÐ*±âŸ: °¡±ÞÀû ¹Ù·Î ¾÷¹« ½ÃÀÛÀÌ °¡´ÉÇϽŠºÐ(ASAP)
Á÷¾÷Á¤º¸Á¦°ø»ç¾÷½Å°í¹øÈ£ J150002023003