- 目录
岗位职责是什么
临床试验专员是一个关键的角色，主要负责确保临床研究项目的合规性、质量和进度，以推动新药或医疗设备的研发进程。这一职位需要深入理解临床试验的各个环节，并与多个部门和外部合作伙伴紧密协作。
岗位职责要求
1. 具备医学、药学或相关科学领域的学士学位，硕士或博士背景优先。
2. 至少2年的临床试验管理经验，熟悉ich-gcp和相关法规。
3. 精通临床试验流程，包括试验设计、患者招募、数据管理、监查和报告撰写。
4. 强烈的责任心和职业道德，能够处理多任务并保持高效。
5. 出色的沟通和协调能力，能够与研究团队、伦理委员会、cros及监管机构有效合作。
6. 熟练使用临床试验相关软件和数据库，如ectr, ctms等。
岗位职责描述
临床试验专员的核心工作是协调和执行临床试验的各个方面，确保试验按照预设的时间表和质量标准进行。他们需密切关注试验进展，识别潜在问题并提出解决方案，以防止延误。此外，他们还需准备和审核临床试验文档，如研究方案、病例报告表和监查报告，确保其准确无误。
在患者招募阶段，临床试验专员需要与研究团队紧密合作，确保患者招募策略的有效实施，同时保证患者权益得到充分保护。在数据管理环节，他们负责监督数据的收集、录入和校验，确保数据的完整性和准确性。
有哪些内容
1. 项目管理：制定和维护临床试验时间线，协调内部资源和外部供应商，确保项目按计划进行。
2. 合规监控：确保所有活动符合gcp标准和当地法规，参与内部和外部审计，解决合规问题。
3. 文件管理：编写和审阅临床试验相关文件，包括研究协议、知情同意书和监查报告。
4. 患者关怀：协助研究团队进行患者筛选、入组和随访，处理患者疑问和投诉。
5. 数据质量管理：监控数据完整性，处理数据缺失或异常，与数据管理团队共同确保数据质量。
6. 沟通协调：与研究者、伦理委员会、赞助商和其他利益相关者保持良好沟通，解决合作中的问题。
7. 风险管理：识别和评估临床试验中的风险，制定并实施风险缓解策略。
8. 培训指导：为研究团队提供gcp培训和临床试验操作指导。
临床试验专员的角色是确保临床研究的顺利进行，他们的工作对于推动医药创新和改善患者治疗至关重要。他们需要不断适应变化的法规环境，持续提升专业技能，以应对临床试验领域的挑战。
临床试验专员岗位职责范文
第1篇 临床试验专员岗位职责
临床试验专员 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
