CRA面试常见问题之专业技能相关（1）
查了知乎和公众号很多的文章，结合面试经验总结了外企面试涉及专业技能的问题，同步准备了英文回答，自己也可以备好提前关键字和词组然后组织语言回答（相关英语回答也是精简，自己可以酌情增添）~~~遇到没有处理或者接触过的环节也不要慌，分点将自己能够想到的解决措施或者问题角度都说出来，让manager感受到你有头脑，思路方向都是清晰的。下面主要从clinical trail 各个环节分点介绍。
Research team have gcp certificate and have clinical trials experience and fully recognized research products；The site is able to ensure sufficient patient screening and enrollment
在项目组通知要进行中心调研的时候，即可提前在官网查阅中心调研的办事流程，如果没有详细要求，致电机构与其沟通调研流程；同步和最近在此中心完成过调研工作的同事或者朋友沟通是否有和特别需要注意事项，比如科室实际病源量和积极负责的PI是否会与机构推荐的不一致，近期是否有较多竞争项目；在通过机构初步调研获取推荐PI的联系方式后，先发短信将本项目的简要信息研究者一例费用/适应症/组长单位/研究药物/几期临床试验/申办方/cro控制在两百字内发送PI，如果在一天内未得到答复后，致电PI沟通初步意向和拜访时间；正式拜访时提前在官网将PI信息获取制作PI简历，再带上方案摘要、保密协议等正式和PI沟通。完成调研流程。When the project team notifies Confirmation of Site Selection Visit, it can consult the work flow of the center in advance on the official website. If there is no detailed requirement, call the organization to communicate the investigation flow with it. Synchronize（同步[?s??kr?na?z]）and communicate with colleagues （colingus）or friends who have recently completed the Site Selection work ，whether there are and special precautions（[pr??k????nz]）, such as the actual disease（[d??zi?z]）source ，and the PI who is actively responsible for it It will be inconsistent（[??nk?n?s?st?nt]）with the recommendation（[?rek?men?de??n]）of the institution（[??nst??tju??n]）, whether there are more competitive（[k?m?pet?t?v]）projects in the near future; after obtaining the contact information of the recommended PI through the preliminary（[pr??l?m?n?ri]初步地）investigation of the institution, send a short message to control the brief information of the project within 200 words of the investigator's case cost / indication / Team leader unit / research drug / several clinical trials / sponsor / cro; if there is no reply within one day, call the PI to communicate at the beginning Step intention and visit time; during the official visit, obtain PI information on the official website in advance and make PI resume, and then bring the scheme（[ski?m]）summary, confidentiality （[?k?nf??den?i??l?ti]）agreement，FEASIBILITY QUESTIONNAIRE and other formal communication with PI. Complete the research process（[?pr??ses , pr??ses]）.
在项目组通知中心调研成功的时候，即可在官网查阅立项伦理的办事流程，如果没有详细要求，致电机构与其沟通立项伦理流程；同步和最近在此中心完成过立项伦理工作的同事或者朋友沟通是否有和特别需要注意事项，比如中心对知情一定要加上的受试者利益或者不准进行的事项、中心特定文件如无利益冲突说明、不开研究者会议不能立项，立项费用需要提前打到机构、立项需要进行系统上传审核等等？尽量能够提前获知阻力信息，尽量和项目组这边协调准备好相关文件和要求；一般的立项要求是分为电子系统上传审核、现场资料审核和二者都需要，先按照机构要求申请电子系统账号或者发邮件预约预约资料审核时间，电子审查过了以后再进行纸质资料现场审核；在立项时同步预约伦理时间，争取无缝衔接流程，将进度推进，提前争取赶上当月或者最近的一次伦理会议，能做的努力是：按照伦理要求准备文件、按照约定时间提前递交伦理资料、支付伦理加急审查费、争取PI资源去和伦理沟通、日常和伦理老师刷脸熟、项目组争取资源去比如提供伦理委员的加急费或者提供果盘盒饭等福利...
在中心调研成功时即可准备协议工作，最晚不超过立项成功，因为一般常规中心拿到伦理批件即可审核协议，有些site可以同步审核；提前和最近在此中心完成过协议工作的同事或者朋友沟通是否有和特别需要注意事项：比如对于某些条款审核比较强势、使用医院模板整体流程会推进的非常快反之需要时间大幅加强；和机构沟通费用收集是机构统一报价还是根据科室来，一定需要将费用和研究者、机构确认到位，特别是涉及比如影像评估费用和护士采血费，机构发放研究者费用是否及时，需不需要将研究费用给到明面上的是一部分其他的按照别的形式比如推荐费给到研究者，后续如果费用分配不到位会影响团队积极性，费用一定要各方满意无异议；项目组定稿协议后及时递交给机构，根据机构的态度和要求至少每周进行一次跟进督促，确保项目进度。如果机构feedback滞后非常多，跟进安排适当进行onsite拜访、动用LM/PM资源进行协调访视、动用PI的积极性推动；同时对于机构的feedback一定要督促PM/sponsor2-3个工作日给出feedback；
1、准备工作：存放研究产品的冰箱已经试运行成功研究产品申请到位寄送到药房、相关的离心机等物资已经到位、按照项目组SOP相关的表格已经寄到site（启动会签到表，site visit log, 授权表，培训记录表，研究者简历模板，受试者筛选入选表，鉴定代码表，知情同意书，方案，入排卡，受试者日记卡）；熟悉透彻方案、积极参加项目组对于方案&中心实验室&AE&AESI等培训、和PM对于启动会PPT进行预演；和PI沟通确认好参会人数地点，邀请机构和GCP药管员参会，通知工作做到位；对于site流程再和CRC预演一遍，确保中心目前是可以会后立即能够进入筛选入组工作。
2、启动会当天的水果盒饭已经到位，开始启动会的时候要讲好PPT，尤其是入排标准，入组目标，试验流程，节点都需要在启动会上给研究者讲解清楚。对于会上疑问积极进行解答，如果有不能确定的可以和老师告知会后和项目组沟通后在答复，全程自信和专业。
3、启动结束后针对会上遗留问题积极汇总发给项目组，及时feedback研究者；按照SOP及时撰写SIVR；跟进CRC需要签字的文件，收集的简历以及资质证书等等。
1. Preparation: the refrigerator for storing the research products has been put into trial operation successfully, the application for the research products has been in place and sent to the pharmacy, relevant centrifuges and other materials have been in place, and the relevant forms according to the SOP of the project team have been sent to site ; familiar with the thorough scheme, actively participate in the project team's training on Scheme & Central Laboratory & AE & AESI, and PM's preview of the start-up meeting ppt; communicate with PI to confirm the number and location of participants, invited institutions and GCP Administrators attended the meeting and informed the work to be done in place; for site process and CRC rehearsal again, to ensure that the site can enter the screening team immediately after the meeting.
2. The fruit box meal on the day of the kick-off meeting has been in place. When the kick-off meeting starts, PPT should be explained well, especially the Inclusion and exclusion criteria, entry objectives, test process and nodes, which should be explained clearly to the researchers at the kick-off meeting. Actively answer the questions at the meeting. If you are not sure, you can communicate with the project team after the meeting, and then reply with full confidence and professionalism.
3. After the start-up, the problems left over in the meeting will be collected and sent to the project team, and the feedback researchers will be in time; the sivr will be written in time according to the SOP; the documents that need to be signed by the CRC will be followed up, and the resumes and qualification certificates collected will be followed up.
主要从以下几方面进行，第一点，拜访前提前发邮件和电话预约研究者和CRC的时间，地点；根据SOP准备好各种tracker和需要递交备案的文件。第二点，从以下几方面开展监查工作，首先是研究者文件夹的整理，例如更新的知情、方案、药检报告和上报的PD等文件有没有及时递交伦理，相关伦理批件已取回，接下来查看受试者文件夹相关信息：知情已签署、版本号日期无错误；原始记录及时且真实；访视有无超期；AE和合并用药及时记录且对药物相关性进行判断等等；再然后查看研究药物相关信息：新药的运输温度及签收入库保存记录；药物的发放和回收；受试者日记卡和原始记录的核对；进行CRF 的SDV。最后查看研究人员的授权信息和实际操作内容是否符合，是否新增研究者，相关文件进行准确有效收集，相关试验设备和实验室正常值范围是否有效期内。第三点，根据此次监查到的一些common问题拜访研究者，提醒督促避免类似问题产生；督促入组工作；沟通site是否有困难，需要我们支持的工作。第四点，监查结束之后根据SOP写监查报告，报告定稿后发follow up letter将问题汇总邮件给到crc和研究者，后续督促跟进中心解决遗留问题。
Contact the CRC and researchers in advance before the MV to confirm whether they are all in the site。In the monitoring, firstly, the researcher's folder and the subject's folder were sorted out, the his was checked, and the data of patient's medical history combined with medication combined with disease was traced. Go to the pharmacy to check the quantity of drugs and check the inventory; summarize the problems of this audit, visit the researchers and urge enrollment.After the monitor, the problem summary email will be sent to the CRC and researchers, and then the follow-up site will be urged to solve the problem