乐百家lom599手机版1. Participated in the preliminary preparation work of screening, project approval, ethics, organization of research meeting, etc. of the clinical trial center;
乐百家lom599手机版2. Initiated, monitored and closed clinical trials in accordance with the study plan, GCP and company SOP.
3. Assist PM to solve problems related to research in research institutions, ethics and departments.
乐百家lom599手机版4. Monitor the quality of clinical research, track the progress of research and coordinate the work of clinical trials;
乐百家lom599手机版5. Assist PM to complete the material distribution, contract payment, and seal the summary report.
1. Major in medicine, clinic, nursing and related, bachelor degree or above.
2. Clear written and oral expression skills, good at active and active communication.Able to travel frequently and work under high pressure.
乐百家lom599手机版3. Excellent problem solving ability and good team spirit.
乐百家lom599手机版4. CET-4 or above, CET-6 preferred, proficient in listening, speaking, reading and writing.
乐百家lom599手机版5. Proficient in various Microsoft office software and familiar with various applications of network tools.
乐百家lom599手机版6. Over 1 year working experience in the industry.
1. Assist QC manager and/or project manager to develop project quality control plan to ensure clinical trials are performed in accordance with GCP, SOP and related regulatory requirements.
2. Assist QC manager to develop and update QC SOPs and instruction manual.
3. Complete the project quality control independently according to the quality control plan, and ensured the implementation of the project in accordance with relevant laws and regulations, GCP, SOP and customer requirements.
4. Record all quality control findings and discuss with relevant responsible personnel to provide solutions. Finish QC report and follow all Action until problem is solved and offer advice to CRA.
5. Participate in the training of QC, and prepared relevant training documents.
1. Major in medicine, bachelor's degree
2. At least 2 years of clinical research experience
乐百家lom599手机版3. Good English (writing and reading)
乐百家lom599手机版4. Familiar with GCP, ICH-GCP and other relevant regulations
乐百家lom599手机版5. Familiar with office and other skills
乐百家lom599手机版6. Good communication and presentation skills
1. Assist in the preparation of clinical trials;
乐百家lom599手机版2. Assist in contacting the ethics committee of the institution;
3. Assist investigators to explain the trial procedures to patients and obtain informed consent;
4. Communicate with investigators, sponsors or CRO companies when necessary;
5. Complete the report of SAE under the guidance;
6. Assist the investigators to fill in, input and answer CRF forms under the guidance, and complete the file management according to the project;
乐百家lom599手机版7. Assist investigators to screen potential patients and urge them to join the group;
8. Assist in supervision and inspection ;Prepare and provide all required documents for the sponsor.
乐百家lom599手机版1. Bachelor degree or above, major in clinical medicine, nursing, pharmacy, etc.
2. Over 1 year nursing experience is preferred;
3. Familiar with the working process of the hospital, have affinity and strong communication and coordination ability;
4. Self-motivated, strong sense of responsibility, proactive, careful and rigorous.
1. Support department manager/PM/ CRA to finish the work related to the project, including internal work and field work;
2. Supporting the clinical monitoring team by recording the documents related to the progress of clinical trials, so that the team members, customers and auditors can always be fully, timely and consulted at any time;
3. Manage and maintain the archives room;
4. Help customers, team members and other members of the project team to communicate and act;
5. Administrative work, such as copying, fax, scanning, etc.;
6. Project document management, such as time table, project summary, etc.;
7. Arrange meetings, prepare meeting agenda, minutes and related matters of training courses.
1. College degree or above;
2. Have general English skill, cet-4 and cet-6 and above;
3. Have strong communication skills and coordination ability to solve problems;
4. Familiar with Word, Excel, PPT and other related office software.
乐百家lom599手机版1. Develop CRA annual training plan together with training manager.
2. Conduct CRA training according to the training plan, including relevant training PPT and other documents.
乐百家lom599手机版3. Assist the training manager in development and implementation of training assessment methods.
乐百家lom599手机版1. Major in medicine, bachelor's degree
2. At least 3 years of clinical trial experience
3. Good English (reading and writing)
乐百家lom599手机版4. Familiar with GCP, ICH-GCP and other relevant regulations
乐百家lom599手机版5. Familiar with office software, especially Power Point
1. Responsible for investigation, selection and provision of relevant information of site investigators. Provide test related information in time according to test progress.
乐百家lom599手机版2. Organize, prepare and attend the investigators' meeting and make corresponding minutes at the meeting, responsible for the liaison and reception of site investigators.
3. Conduct comprehensive management of sites, strictly follow the GCP, SOP, and Chinese laws and regulations, and complete the selection, start-up, routine monitoring and closure of the site on time within the project plan time limit.
乐百家lom599手机版4. Timely complete high-quality site visit report.
乐百家lom599手机版5. Assist the research center in reporting AE/SAE and follow up.
乐百家lom599手机版6. Ensure the safety and interests of the subject by verifying the informed consent process.
乐百家lom599手机版7. Ensure the authenticity, accuracy and completeness of the data through the verification of original data and the management of case report/data inquiry form.
8. Manage the study materials at sites, including IPs, study documents and related test equipment.
乐百家lom599手机版9. Responsible for discussing with the main investigators of the sites about clinical trial agreements
10. Coordinated the preparatory work before the inspection of the site, complete the feedback of the inspection report of the site, formulated the rectification plan, and completed the work in the rectification plan on time.
乐百家lom599手机版11. Provide training for investigators on protocol, GCP, CRF, etc.
12. Provide the site, local project team and management with the latest information about the trial.
乐百家lom599手机版13. Develop good cooperative relations with investigators.
乐百家lom599手机版14. Cover all other duties of the supervisor and be able to deal with emergency emergencies in a timely manner, and be the main emergency backup candidate for CRA and projects.
乐百家lom599手机版1. Bachelor degree or above in clinical or pharmaceutical related maojor.
2. At least 5 years of clinical trial experience in pharmaceutical enterprises or CRO.
乐百家lom599手机版3. Proficient in various Microsoft office software.
4. Proficient in English; able to independently consult relevant literature and materials; able to write English project progress report and QC report. Be able to communicate and communicate with the bid staff in good English.
5. Clear written and oral communication skills, good at active and active communication;
6. Good at communicating with different types of customers and able to establish good relationships;
7. Excellent team organizing ability/project management skills;
乐百家lom599手机版8. Strong problem solving ability and emergency plan management ability;