How do you perform onsite monitoring visit?
Preparation: Book time with site staff, review last MVR to see if any pending issues or actions, run trackers (IWRS, EDC, lab kits, imaging), maintain own ISF tracker, send confirmation letter to site (mentioning the content of the letter)
During MV: SDV, SDR as per source data agreement, subject visits (new subjects enrolled, ICFs checked, ensure procedures are done as per protocol), IP accountability, inventory, storage, shipment checked, ISF documents checked. At the end of the day, there would be a time for discussing with site staff about issues found, current study status or any recruitment strategies.
After MV: Record all pending actions and issues, discussion, resolved items in the MVR. Send a follow up letter to site to keep track of all pending actions and set a deadline for them.
How do you perform remote monitoring visit?
The only difference compared to onsite MV may be that CRAs need to apply for the access to the EMR of the hospital and doing remote checks. The communication would not be in person.
How do you perform eTMF reconcilliation?
Run report in the eTMF system and the report would show if there is any issues found, such as duplicates, missing files to be checked. The system also checked quality issues periodically and CRAs are required to resolve the task within timeline.
What is the most serious issue you found during MV and how do you resolve it?
這個請自行思考囉。我覺得問得很妙，我沒有準備到，當下真的是立即想一個嚴重但處理很好的問題。
Could you tell me your knowledge of RECIST?
自行準備，幸好我有準備，但蠻意外會考我定義跟判定overall response方式。
The SCs in Taiwan is not independent and require lots of assistance from CRAs. What do you think about that?
這是個不錯的問題，我個人是回答交接給我的很多SC已經培養了這種依賴的習慣，因此很難改變，而從我自己開始的新案，我試圖去將責任於一開始就說清楚，讓他們漸漸理解我們的一些協助，並非理所當然。
(追加問題) You will be facing other studies handing over to you and you may not initiate your own sites when you get into the company. Then what could you do?
我使用情境的方式，引導SC意識這個工作 (例如通報PD)是他們的工作，因為整個過程是他們最清楚狀況，若由我們進行填寫，可能無法到位，且有出入。
How many times will PM return your monitoring visit report in average? What are the issues in your report?
Around 1 time each report. 然後形容那些點容易被提醒要修改。
Did you meet database lock timeline on time? How did you manage?
To notify site in advance because database lock is an important timepoint and usually would be announce at least 2 quarters in advance. Therefore, I may schedule a specific time with site a few weeks prior to the actual cleaning starts so that the actual lock would not be so demanding.
What do you think is the most important strength for a CRA job?
這個自行思考~看你優勢在哪囉
What is your weakness? As a manager, I would like to know where to support you when you are my member.
這個自行思考~好好打也是會轉換成優勢!
What do you do to perform a high quality visit?
這題跟我如何perform MV很類似，我也回答蠻類似。除此之外，可能加上定期與site約時間解query、missing data。
Why do you leave your last job?
這題我主要從我現在的工作量與品質的平衡來出發，工時長對於一個人career path 走得長久與否也會很有關係，他們都是外國人，看起來對這點蠻認同的。我也提到公司理念、現任主管與我的相處，難以調整我現存的工作量等難處。
Are you more interested in CRO or pharmaceutical company?
這個依照自己狀況回答~~我回答我prefer 藥廠 (PS 我這個role 是insourcing to sponsor所以我這樣說)
Have you ever meet difficulty in recruiting? What did you do to resolve?
1. 先了解醫師目前對於案件的信任度，及現存early phase的試驗結果是否promising
2. 了解試驗設計、IE criteria 設計上，試驗團隊是否有覺得困難執行的地方，或者任何問題需要協助。
CRA可盡量迅速且明確回覆問題的狀態下，可能能使醫院端覺得這試驗不麻煩、且有人強力support的。
Have you ever performed COV?
根據你個人狀況回答囉
Where do you see yourself in a two-years of time?
根據你個人狀況回答囉。前面有提到這個是新的model，所以在前面我就有問面試官career development的問題，所以我就直接套用他前面講的那些出路。
How many days a month do you perform onsite monitoring visit in average?
Based on the study status. As for this year, 10-13 days onsite in the first quarter.
What do you think is the biggest difference between oncology studies and other studies when performing MV?
先備知識 (疾病本身、常用藥物及治療、預後)等
There are lots of AE and SAEs, concomitant medications of cancer patients. How do you go through this huge amount of data during your routine monitoring visit?
我沒預期會問到這個，我就說EMR看過去然後用filter、做excel之類XD 太臨時想了
What is your current salary and your expected salary?
照實回答。但我也沒料到他們會問，通常好像都是HR經手這種問題。
