問 最近看到有招(zhao)聘CRA臨(lin)床(chuang)監查員的(de)，想咨詢一下，CRA臨(lin)床(chuang)監查員的(de)崗位職(zhi)責是什么(me)？

答(da) 1.研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)中(zhong)(zhong)(zhong)心(xin)(xin)(xin)(xin)篩選、啟動(dong)（SIV）和(he)(he)(he)(he)監查(cha)(cha)。 2.執行前期(qi)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)訪(fang)(fang)問，確保(bao)根(gen)據(ju)(ju)中(zhong)(zhong)(zhong)心(xin)(xin)(xin)(xin)選擇標準(zhun)選擇合(he)格的(de)(de)(de)(de)(de)中(zhong)(zhong)(zhong)心(xin)(xin)(xin)(xin)，包含但(dan)不限于研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)中(zhong)(zhong)(zhong)心(xin)(xin)(xin)(xin)所(suo)(suo)(suo)擁(yong)有(you)(you)足夠(gou)的(de)(de)(de)(de)(de)資源(yuan)和(he)(he)(he)(he)經驗(yan)。 3.收集研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)中(zhong)(zhong)(zhong)心(xin)(xin)(xin)(xin)倫理遞(di)交要(yao)求，確保(bao)項(xiang)目資料(liao)及(ji)(ji)(ji)時(shi)(shi)遞(di)交倫理，并獲(huo)得倫理審評意見。 4.及(ji)(ji)(ji)時(shi)(shi)完成(cheng)與研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)中(zhong)(zhong)(zhong)心(xin)(xin)(xin)(xin)的(de)(de)(de)(de)(de)協議(yi)商談及(ji)(ji)(ji)簽署。 5.準(zhun)備(bei)和(he)(he)(he)(he)完成(cheng)中(zhong)(zhong)(zhong)心(xin)(xin)(xin)(xin)啟動(dong)訪(fang)(fang)視， 確保(bao)相關(guan)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)中(zhong)(zhong)(zhong)心(xin)(xin)(xin)(xin)人(ren)員(yuan)獲(huo)得足夠(gou)的(de)(de)(de)(de)(de)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)培(pei)(pei)訓，確保(bao)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)中(zhong)(zhong)(zhong)心(xin)(xin)(xin)(xin)人(ren)員(yuan)按照(zhao)方(fang)(fang)案和(he)(he)(he)(he)相關(guan)法(fa)規實施(shi)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)。 6.跟蹤(zong)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)受試(shi)者招募，確保(bao)招募目標在所(suo)(suo)(suo)有(you)(you)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)中(zhong)(zhong)(zhong)心(xin)(xin)(xin)(xin)完成(cheng)。 7.根(gen)據(ju)(ju)項(xiang)目管理計劃和(he)(he)(he)(he)SOP進(jin)(jin)行監查(cha)(cha)訪(fang)(fang)視；及(ji)(ji)(ji)時(shi)(shi)協調(diao)(diao)解決中(zhong)(zhong)(zhong)心(xin)(xin)(xin)(xin)問題和(he)(he)(he)(he)完成(cheng)監查(cha)(cha)訪(fang)(fang)問報(bao)(bao)告。 8.確保(bao)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)物(wu)資及(ji)(ji)(ji)時(shi)(shi)到位(wei)，協調(diao)(diao)到每(mei)個(ge)(ge)中(zhong)(zhong)(zhong)心(xin)(xin)(xin)(xin)的(de)(de)(de)(de)(de)啟動(dong)階(jie)段及(ji)(ji)(ji)貫穿整個(ge)(ge)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)。 9.給(gei)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)中(zhong)(zhong)(zhong)心(xin)(xin)(xin)(xin)人(ren)員(yuan)提供關(guan)于GCP、研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)方(fang)(fang)案和(he)(he)(he)(he)需求的(de)(de)(de)(de)(de)持續(xu)培(pei)(pei)訓。 10.在研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)的(de)(de)(de)(de)(de)啟動(dong)，進(jin)(jin)行和(he)(he)(he)(he)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)完成(cheng)階(jie)段，按照(zhao)方(fang)(fang)案和(he)(he)(he)(he)法(fa)規要(yao)求，確保(bao)必(bi)要(yao)文件的(de)(de)(de)(de)(de)及(ji)(ji)(ji)時(shi)(shi)獲(huo)得；保(bao)持和(he)(he)(he)(he)更(geng)新(xin)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)中(zhong)(zhong)(zhong)心(xin)(xin)(xin)(xin)檔案和(he)(he)(he)(he)試(shi)驗(yan)總(zong)檔案的(de)(de)(de)(de)(de)文件。 11.根(gen)據(ju)(ju)SOP和(he)(he)(he)(he)適(shi)用法(fa)規，確保(bao)藥物(wu)安全信息發布到所(suo)(suo)(suo)有(you)(you)中(zhong)(zhong)(zhong)心(xin)(xin)(xin)(xin)。 12.根(gen)據(ju)(ju)SOP和(he)(he)(he)(he)適(shi)用法(fa)規，確保(bao)所(suo)(suo)(suo)有(you)(you)SAE在規定時(shi)(shi)間內呈報(bao)(bao)。 13.確保(bao)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)費用計劃的(de)(de)(de)(de)(de)精確度(du)和(he)(he)(he)(he)保(bao)留(liu)相關(guan)的(de)(de)(de)(de)(de)文件/收據(ju)(ju)。 14.及(ji)(ji)(ji)時(shi)(shi)更(geng)新(xin)和(he)(he)(he)(he)維護研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)工具/系統。