問 最近看到有(you)招聘CRA臨床(chuang)監查員的(de)，想(xiang)咨詢一下，CRA臨床(chuang)監查員的(de)崗位職責是什么？

答 1.研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)中(zhong)(zhong)心(xin)篩選、啟(qi)動(dong)(dong)（SIV）和(he)(he)(he)(he)(he)監查(cha)(cha)。 2.執行(xing)前期研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)訪問，確(que)(que)(que)(que)保(bao)(bao)(bao)(bao)(bao)根據(ju)中(zhong)(zhong)心(xin)選擇標準選擇合格(ge)的(de)(de)中(zhong)(zhong)心(xin)，包含但(dan)不限于(yu)研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)中(zhong)(zhong)心(xin)所擁有(you)足夠的(de)(de)資源和(he)(he)(he)(he)(he)經驗。 3.收(shou)集(ji)研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)中(zhong)(zhong)心(xin)倫(lun)理遞交要求，確(que)(que)(que)(que)保(bao)(bao)(bao)(bao)(bao)項目(mu)資料(liao)及(ji)時(shi)遞交倫(lun)理，并獲(huo)(huo)得倫(lun)理審評意見。 4.及(ji)時(shi)完(wan)(wan)成與研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)中(zhong)(zhong)心(xin)的(de)(de)協議(yi)商談及(ji)簽署。 5.準備(bei)和(he)(he)(he)(he)(he)完(wan)(wan)成中(zhong)(zhong)心(xin)啟(qi)動(dong)(dong)訪視(shi)， 確(que)(que)(que)(que)保(bao)(bao)(bao)(bao)(bao)相(xiang)關研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)中(zhong)(zhong)心(xin)人員獲(huo)(huo)得足夠的(de)(de)研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)培(pei)訓，確(que)(que)(que)(que)保(bao)(bao)(bao)(bao)(bao)研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)中(zhong)(zhong)心(xin)人員按照方(fang)案和(he)(he)(he)(he)(he)相(xiang)關法規(gui)(gui)(gui)實施研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)。 6.跟蹤研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)受試(shi)者(zhe)招募，確(que)(que)(que)(que)保(bao)(bao)(bao)(bao)(bao)招募目(mu)標在(zai)所有(you)研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)中(zhong)(zhong)心(xin)完(wan)(wan)成。 7.根據(ju)項目(mu)管(guan)理計(ji)劃(hua)和(he)(he)(he)(he)(he)SOP進行(xing)監查(cha)(cha)訪視(shi)；及(ji)時(shi)協調解決中(zhong)(zhong)心(xin)問題和(he)(he)(he)(he)(he)完(wan)(wan)成監查(cha)(cha)訪問報(bao)告(gao)。 8.確(que)(que)(que)(que)保(bao)(bao)(bao)(bao)(bao)研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)物資及(ji)時(shi)到(dao)位，協調到(dao)每個中(zhong)(zhong)心(xin)的(de)(de)啟(qi)動(dong)(dong)階段(duan)及(ji)貫穿整(zheng)個研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)。 9.給(gei)研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)中(zhong)(zhong)心(xin)人員提供關于(yu)GCP、研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)方(fang)案和(he)(he)(he)(he)(he)需求的(de)(de)持續培(pei)訓。 10.在(zai)研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)的(de)(de)啟(qi)動(dong)(dong)，進行(xing)和(he)(he)(he)(he)(he)研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)完(wan)(wan)成階段(duan)，按照方(fang)案和(he)(he)(he)(he)(he)法規(gui)(gui)(gui)要求，確(que)(que)(que)(que)保(bao)(bao)(bao)(bao)(bao)必要文(wen)件的(de)(de)及(ji)時(shi)獲(huo)(huo)得；保(bao)(bao)(bao)(bao)(bao)持和(he)(he)(he)(he)(he)更新研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)中(zhong)(zhong)心(xin)檔案和(he)(he)(he)(he)(he)試(shi)驗總檔案的(de)(de)文(wen)件。 11.根據(ju)SOP和(he)(he)(he)(he)(he)適(shi)用法規(gui)(gui)(gui)，確(que)(que)(que)(que)保(bao)(bao)(bao)(bao)(bao)藥物安(an)全信息發布(bu)到(dao)所有(you)中(zhong)(zhong)心(xin)。 12.根據(ju)SOP和(he)(he)(he)(he)(he)適(shi)用法規(gui)(gui)(gui)，確(que)(que)(que)(que)保(bao)(bao)(bao)(bao)(bao)所有(you)SAE在(zai)規(gui)(gui)(gui)定時(shi)間內呈報(bao)。 13.確(que)(que)(que)(que)保(bao)(bao)(bao)(bao)(bao)研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)費用計(ji)劃(hua)的(de)(de)精確(que)(que)(que)(que)度和(he)(he)(he)(he)(he)保(bao)(bao)(bao)(bao)(bao)留相(xiang)關的(de)(de)文(wen)件/收(shou)據(ju)。 14.及(ji)時(shi)更新和(he)(he)(he)(he)(he)維(wei)護研(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)工具/系(xi)統。