Place of work：Beijing, Hangzhou, Nanchang, Chengdu, Changsha, Shanghai, Wuhan
Date of issue： 2020-12-08
operating duty：
Clinical Research Associate (CRA)
Position Description:
1. Ensure that the clinical trial is conducted in accordance with national GCP requirements and the trial protocol through a standardized monitoring process.
2. Correct storage, dispensing, and use of investigational drugs and articles.
3. Fill in the relevant reports and trial records to ensure that the data are true, accurate and complete.
Job Requirements:
1. Major in medicine or pharmacy and related specialties, bachelor's degree or above.
2. 1-3 years of working experience of CRA in CRO industry or pharmaceutical enterprises.
3. Be familiar with Provisions for Drug Registration, drug clinical trial, GCP and other relevant regulations.
4. CET-4 or above level.
5. Have good interpersonal relationships and good communication and language expression skills.
Cities where recruiting staff is ongoing:
Beijing, Hangzhou, Nanchang, Chengdu, Changsha, Shanghai, Wuhan
Clinical Research Coordinator (CRC)
Position Description:
Assist the investigator in completing various works according to the requirements of GCP and the study protocol.
1. Assist the investigator in completing the work of submission of ethical materials, filing of pharmacological institutions, contract signing and others; assist in timely completing SAEs, SUSARs and other relevant safety reports.
2. Assist the investigator in completing the collection, collation and archiving of documents from the site at each phase of the trial.
3. Assist the investigator in completing the management of subjects, including subject recruitment, screening potential subjects, arranging subject visits, arranging laboratory tests, obtaining test results and others.
4. Assist the investigator in completing the handling, preservation and transportation of the test specimens.
5. Assist the investigator in completing the management and counting of clinical study drugs and related materials, including the receipt, preservation, distribution, recovery and return of drugs and related materials, and completing relevant records.
6. Assist the investigator in completing the case report form and resolution of discrepancies (except for those requiring medical judgment) under the authorization of the investigator.
7. Coordinate the site visits by CRA and prepare various documents in advance for monitoring by CRA.
8. Conduct comprehensive communication (mail, oral, fax) with site personnel, the sponsor and others according to the trial plan and record them.
9. Assist the investigator in completing other relevant work of the clinical trial.
Job Requirements:
1. Educational Background:
Junior college degree or above, and major in medicine and related specialties is required. Pharmacist, nurse and medical technician are preferred, and those with relevant experience in clinical research are preferred.
2. Work Experience Requirements:
Working experience in clinical medicine or nursing, especially in clinical pharmacology.
3. English Proficiency:
CET-4 or above level.
4. Computer Literacy:
Be familiar with office softwares such as Word, Excel, PPT, Outlook, etc.
5. Others:
Pay attention to details; good communication and coordination abilities; good time management ability; good problem analysis and solution abilities.
Cities where recruiting staff is ongoing:
Beijing, Shanghai, Guangzhou, Shenzhen, Nanjing, Suzhou, Hefei, Linyi, Yantai, Hangzhou, Tianjin
Clinical Pharmacology Scientist
Position Description:
1. Communicate and cooperate with statisticians, statistical analysis programmers and other relevant project staff to support clinical pharmacology-related work during drug clinical development.
2. Assist in analyzing information related to pharmacokinetics/pharmacodynamics (PK/PD), safety, efficacy and others of innovative drugs.
3. Assist in the design of early clinical trials of innovative drugs;
4. For innovative drugs in the non-clinical to clinical transition phase, assist in the prediction of human PK/PD profile, dose selection in the first-in-human (FIH) trial, writing the clinical pharmacology section in the FIH clinical study protocol or clinical study protocol and others.
5. Assist and participate in the design and writing of the clinical pharmacology trial protocol and writing of the trial report. Be able to calculate PK parameters independently based on non-compartmental analysis methods. These protocols generally include SAD/MAD, BA/BE, food effects, special population trials, DDIs, etc.
6. Assist in the conduct of quantitative pharmacology studies (ie, modeling and simulation analyses), including population PK analysis, PK/PD analysis, and dose-response (E-R) analysis.
7. Assist in writing the clinical pharmacology section of the drug in the regulatory submissions.
8. Be able to independently perform quality control of clinical pharmacology-related projects.
9. Participate in project management of clinical pharmacology-related projects, participate in external communication on projects, and coordinate project team staff to complete the projects according to scheduled time.
Job Requirements:
1. Major in clinical pharmacology, biopharmaceutics, clinical pharmacy, clinical medicine, biology and other medicine-related specialties, master's degree or above.
2. Participate in project management, have communication and coordination abilities and teamwork spirit.
3. Strong learning and problem analysis and solution abilities.
4. Good reading and written communication skills in English and Chinese.
Cities where recruiting staff is ongoing:
Beijing, Shanghai
Statistical Programmer
Position Description:
1. Programming according to the statistical analysis plan and be responsible for the generation and QC of SDTM and ADaM.
2. Performing statistical reports, graphing and QC.
3. Assist data management personnel in data cleaning.
4. Carry out the work according to the relevant SOP/GCP.
5. Senior Statistical Programmer is responsible for developing programming plans, leading the Project Programmers to complete work delivery on time and ensure quality.
Job Requirements:
1. Full-time bachelor's or master's degree.
2. Major in statistics, mathematics, computer, medicine and other related specialties.
3. More than 1 year of working experience in programming SAS software or programming other data analysis software, senior statistical programmer must have more than 3 years of relevant working experience.
4. Fluent in English reading and writing.
Cities where recruiting staff is ongoing:
Beijing, Shanghai, New Jersey, USA
Clinical Data Manager
Position Description:
1. Participate in the design, preparation and revision of case report forms.
2. Participate in writing documents related to clinical data management and be responsible for preservation, update and archiving.
3. Participate in developing data verification plan and performing database testing.
4. Clean the data according to the data verification plan and carry out query management.
5. Assist in completing various tasks of database lock.
Job Requirements:
1. More than one year of experience in data management.
2. Full-time bachelor's degree, major in medicine, pharmacy or nursing related.
3. Skilled in English reading and writing, CET-4 or CET-6.
4. For Lead DM, more than 4 years of relevant experience are required and lead project experience is no less than 1 year.
Cities where recruiting staff is ongoing:
Nanjing, Hefei, Wuhan
