Hello, everyone
Recently, we are actively engaged in diffierent campus recruitment
Feel the love of many babies
Today, R came to chat with you~
What needs to be done in clinical trials?
What do CRC and CRA need to do?
Are these all in line with my major?
(Omit 100 questions here...)
Don't worry
Let me take out the Sacred scroll and answer it one by one
Knock on the blackboard, class starts!!!
01 What is a clinical trial of medical devices?
Clinical trial of medical device refers to the verification of whether the theoretical principles, basic structure, performance and other elements of the medical device can ensure safety and effectiveness through clinical use. In short, the purpose of clinical trials of medical devices is to evaluate whether the tested products have the expected safety and effectiveness.
Let's imagine
There is a rice cooker manufacturer
Before the new electric rice cooker goes on sale
Its performance and security need to be verified
Here comes the problem
How to evaluate the performance and safety of electric rice cooker?
This needs to be used and evaluated in practical application scenarios
And this process of use and evaluation
Can be compared to clinical trials of medical devices
02 What are these positions for?
①.CRC：
Clinical Reseach coordinator, he is the right-hand assistant of our clinicians. He can help doctors deal with work that does not involve medical judgment. He is an important bridge between researchers, supervisors and subjects.
Preoperative screening, surgical coordination, follow-up, data collection and entry, etc. can all be inseparable from our CRC partners!
Responsibilities：
1. Assist the researcher to complete the management, recruitment and visit of subjects;
2. Assist researchers to complete the submission of ethical materials, and assist in the research and completion of SAE, AE and other relevant safety reports;
3. Assist in the data collection, sorting and archiving of clinical trial projects;
4. Assist in the management of device test and complete relevant records;
5. Assist researchers to cooperate with the central supervision of CRA and prepare various documents for CRA supervision in advance.
Requirements：
1. Nursing, pharmacy, clinical medicine and other related majors;
2. Clinical experience is preferred;
3. Strong independent working ability and teamwork spirit;
4. Have a sense of responsibility, positive and enterprising, cautious and meticulous, and strong organization.
②.CRA：
If there are only traffic regulations without traffic police enforcement, the regulations will not be effectively implemented.
In our clinical trials, CRA is the existence of traffic police. It supervises and ensures that the implementation process of clinical trials meets the requirements of relevant regulations and process guidelines of various hospitals, including screening center, project ethics, screening and enrollment, follow-up, conclusion and other stages.
It's all kinds of worry
From time to time, he has to incarnate the glowing Altman
Wipe out the little monsters who want to destroy peace all over the world!!!
Responsibilities：
1. Implement the supervision of the clinical research center in charge according to the supervision plan;
2. Ensure that the clinical trials of the research center are carried out in strict accordance with the protocol, GCP and relevant laws and regulations, and protect the rights and interests of subjects;
3. Assist researchers in solving possible problems during the experiment;
4. Ensure that the research data are recorded in the case report in a timely, accurate and complete manner;
5. Collect, sort out and archive the research documents according to SOP;
6. Be able to undertake the work of project assistant and assist the project manager in quality control of clinical research;
7. Complete other related work assigned by PM manager.
Requirements：
1. Bachelor degree or above, major in medicine or related life sciences;
2. Have strong team spirit, communication and problem-solving ability, and be able to business travel;
3. Those who have participated in formal GCP training are preferred.
None of this is for you?
Don't panic, don't panic!
There are countless "tricks" of R!
Take it!
③.CTA:
If you are good at document management and data analysis, you must not miss CTA, our clinical trial assistant.
Responsibilities：
1. Assist PM and CRA to manage trial related documents, such as collection, scanning, copying, archiving and maintenance of clinical trial research data;
2. Cooperate with PM to collect the information of research institutions from CRAs and update the project management tracker;
3. Assist in the management of test materials, and complete the distribution, recovery and destruction of project materials after the approval of the project manager;
4. Coordination of clinical trial related meetings and training, such as arrangement and recording of research meetings;
5. Other support work for CRA team.
Requirements：
1. Bachelor degree or above in medicine and health and other related majors;
2. Be familiar with the application of word, Excel and other office software;
3. Good Chinese expression skills, able to sort out basic English documents;
4. Have a certain understanding of clinical trials and relevant laws and regulations of domestic clinical trials;
5. Have basic communication skills, strong sense of responsibility, hard-working and willing to learn；
"R, English is my partner. I can't live without it ~"
——Questions from masters
That's not to worry!
The show time of "medical specialist" begins!
④.Medical specialist：
Protocol writing, literature retrieval, medical training, etc. How to design and build our clinical trial protocol depends on Ta!
Responsibilities：
1. Communicate with the sponsor and investigator, and be responsible for the design and writing of clinical data such as clinical trial protocol and clinical trial report;
2. Provide medical support for the project team and provide training on medical knowledge and protocol in relevant treatment fields;
3. Assist the project in medical audit, including reviewing SAE and protocol deviation;
4. Search domestic and foreign medical literature and provide relevant medical information support;
5. Participate in the organization and implementation of clinical projects;
6. Establish good cooperation and communication relations with experts in important academic fields;
7. Carry out regular medical training for internal employees of the company;
8. Assist and cooperate with the coordination work of other departments.
Requirements：
1. Master degree or above, major in medicine, pharmacy, medical imaging and other related majors;
2. Proficient in Chinese and English literature retrieval, interpretation, analysis, sorting and summary writing;
3. Strong communication and coordination skills and teamwork skills.
The above is the R's thoughts
If you are still confused
Come to links for a "heart to heart communication" with R
Delivery mailbox: hr@linksmed.cn
Or scan the QR code below and add HR wechat
Snack and milk tea is ready. Welcome to my side
Choose all kinds of benefits,take you to the new life
LINKS CRO
As a CRO company providing clinical trial services. LINKS CRO focus on innovation, high-risk implantation(intervention) medical device, with one-stop clinical trial solutions for the whole process of medical device research and development.The headquarters of LINKS is based in Shanghai, with subsidiary branches in Beijing, Shanghai, Guangzhou, and Shenzhen, in addition to ten regional offices. The current workforce comprises almost 200 employees, with technical personnel making up over 85% and dispersed across almost 30 cities nationwide.
Key Services include CRO, SMO, CER, Audit, Post-market research, core laboratory registration both domestically and overseas, innovation declaration, Expert Consultancy, and overseas enterprise agency services.
Key Indications include Cardiovascular, Neurovascular, Peripheral Vascular, Surgery Robot, Oncology, Ophthalmology, Medical Cosmetology, and other fields such as orthopedics. There are almost 300 projects consultations and services by LINKS each year.
