- 目錄
崗位職責(zé)是什么
臨床試驗(yàn)專員是一個(gè)關(guān)鍵的角色，主要負(fù)責(zé)確保臨床研究項(xiàng)目的合規(guī)性、質(zhì)量和進(jìn)度，以推動(dòng)新藥或醫(yī)療設(shè)備的研發(fā)進(jìn)程。這一職位需要深入理解臨床試驗(yàn)的各個(gè)環(huán)節(jié)，并與多個(gè)部門和外部合作伙伴緊密協(xié)作。
崗位職責(zé)要求
1. 具備醫(yī)學(xué)、藥學(xué)或相關(guān)科學(xué)領(lǐng)域的學(xué)士學(xué)位，碩士或博士背景優(yōu)先。
2. 至少2年的臨床試驗(yàn)管理經(jīng)驗(yàn)，熟悉ich-gcp和相關(guān)法規(guī)。
3. 精通臨床試驗(yàn)流程，包括試驗(yàn)設(shè)計(jì)、患者招募、數(shù)據(jù)管理、監(jiān)查和報(bào)告撰寫。
4. 強(qiáng)烈的責(zé)任心和職業(yè)道德，能夠處理多任務(wù)并保持高效。
5. 出色的溝通和協(xié)調(diào)能力，能夠與研究團(tuán)隊(duì)、倫理委員會(huì)、cros及監(jiān)管機(jī)構(gòu)有效合作。
6. 熟練使用臨床試驗(yàn)相關(guān)軟件和數(shù)據(jù)庫，如ectr, ctms等。
崗位職責(zé)描述
臨床試驗(yàn)專員的核心工作是協(xié)調(diào)和執(zhí)行臨床試驗(yàn)的各個(gè)方面，確保試驗(yàn)按照預(yù)設(shè)的時(shí)間表和質(zhì)量標(biāo)準(zhǔn)進(jìn)行。他們需密切關(guān)注試驗(yàn)進(jìn)展，識(shí)別潛在問題并提出解決方案，以防止延誤。此外，他們還需準(zhǔn)備和審核臨床試驗(yàn)文檔，如研究方案、病例報(bào)告表和監(jiān)查報(bào)告，確保其準(zhǔn)確無誤。
在患者招募階段，臨床試驗(yàn)專員需要與研究團(tuán)隊(duì)緊密合作，確保患者招募策略的有效實(shí)施，同時(shí)保證患者權(quán)益得到充分保護(hù)。在數(shù)據(jù)管理環(huán)節(jié)，他們負(fù)責(zé)監(jiān)督數(shù)據(jù)的收集、錄入和校驗(yàn)，確保數(shù)據(jù)的完整性和準(zhǔn)確性。
有哪些內(nèi)容
1. 項(xiàng)目管理：制定和維護(hù)臨床試驗(yàn)時(shí)間線，協(xié)調(diào)內(nèi)部資源和外部供應(yīng)商，確保項(xiàng)目按計(jì)劃進(jìn)行。
2. 合規(guī)監(jiān)控：確保所有活動(dòng)符合gcp標(biāo)準(zhǔn)和當(dāng)?shù)胤ㄒ?guī)，參與內(nèi)部和外部審計(jì)，解決合規(guī)問題。
3. 文件管理：編寫和審閱臨床試驗(yàn)相關(guān)文件，包括研究協(xié)議、知情同意書和監(jiān)查報(bào)告。
4. 患者關(guān)懷：協(xié)助研究團(tuán)隊(duì)進(jìn)行患者篩選、入組和隨訪，處理患者疑問和投訴。
5. 數(shù)據(jù)質(zhì)量管理：監(jiān)控?cái)?shù)據(jù)完整性，處理數(shù)據(jù)缺失或異常，與數(shù)據(jù)管理團(tuán)隊(duì)共同確保數(shù)據(jù)質(zhì)量。
6. 溝通協(xié)調(diào)：與研究者、倫理委員會(huì)、贊助商和其他利益相關(guān)者保持良好溝通，解決合作中的問題。
7. 風(fēng)險(xiǎn)管理：識(shí)別和評(píng)估臨床試驗(yàn)中的風(fēng)險(xiǎn)，制定并實(shí)施風(fēng)險(xiǎn)緩解策略。
8. 培訓(xùn)指導(dǎo)：為研究團(tuán)隊(duì)提供gcp培訓(xùn)和臨床試驗(yàn)操作指導(dǎo)。
臨床試驗(yàn)專員的角色是確保臨床研究的順利進(jìn)行，他們的工作對(duì)于推動(dòng)醫(yī)藥創(chuàng)新和改善患者治療至關(guān)重要。他們需要不斷適應(yīng)變化的法規(guī)環(huán)境，持續(xù)提升專業(yè)技能，以應(yīng)對(duì)臨床試驗(yàn)領(lǐng)域的挑戰(zhàn)。
臨床試驗(yàn)專員崗位職責(zé)范文
第1篇 臨床試驗(yàn)專員崗位職責(zé)
臨床試驗(yàn)專員 position summary
80% fte of this position will support to clinical operation in ma function, 20% fte performs a variety of administrative support to ma senior director and ma team.
key responsibilities
1. clinical trial support
a. trial master file and other study related documents handling and archiving in office
b. clinical trial supplies logistic supporting and tracking
c. clinical trial contract including vendor contract management and supporting
d. clinical trial payment supporting and tracking
e. supporting on organize e_ternal and internal meetings, draft meeting minutes as needed
f. setup and maintain the database(s) in clinical operation as required
g. ma storage room management
2. admin support to ma senior director
a. arrange business trips, including the flight tickets and hotels and visa application as needed
b. logistic support for function visitor(s) in china including but not limited to visa application, hotel booking, administrative communication
c. function administrative file maintenance in ma
d. e_pense report and manage the reimbursement
3. office admin support to ma team:
a. assist internal process (e.g. prpo)
b. collect related information from team member and consolidate reports as needed, e.g. monthly report, etc.
c. function fi_ed assets management
d. assist in new comer on board process
e. be the contact person for department activities
f. assist on department meeting
skills and abilities
1. customer focus and good communication skill
2. good written and spoken english
3. result oriented and self-motivated
4. teamwork spirit
5. accountable with strong ownership
6. good command of ms skill (word, e_cel and powerpoint)
desirable
1. bachelor degree in relative disciplines, biomedical background is preferred
2. at least 2 years relative working e_perience
3. administrative e_perience in related clinical research ( international healthcare companies, or cros) is preferred
position summary
80% fte of this position will support to clinical operation in ma function, 20% fte performs a variety of administrative support to ma senior director and ma team.
key responsibilities
1. clinical trial support
a. trial master file and other study related documents handling and archiving in office
b. clinical trial supplies logistic supporting and tracking
c. clinical trial contract including vendor contract management and supporting
d. clinical trial payment supporting and tracking
e. supporting on organize e_ternal and internal meetings, draft meeting minutes as needed
f. setup and maintain the database(s) in clinical operation as required
g. ma storage room management
2. admin support to ma senior director
a. arrange business trips, including the flight tickets and hotels and visa application as needed
b. logistic support for function visitor(s) in china including but not limited to visa application, hotel booking, administrative communication
c. function administrative file maintenance in ma
d. e_pense report and manage the reimbursement
3. office admin support to ma team:
a. assist internal process (e.g. prpo)
b. collect related information from team member and consolidate reports as needed, e.g. monthly report, etc.
c. function fi_ed assets management
d. assist in new comer on board process
e. be the contact person for department activities
f. assist on department meeting
skills and abilities
1. customer focus and good communication skill
2. good written and spoken english
3. result oriented and self-motivated
4. teamwork spirit
5. accountable with strong ownership
6. good command of ms skill (word, e_cel and powerpoint)
desirable
1. bachelor degree in relative disciplines, biomedical background is preferred
2. at least 2 years relative working e_perience
3. administrative e_perience in related clinical research ( international healthcare companies, or cros) is preferred
