Main post responsibilities:

Work place: Suzhou 

Responsibilities:

1. Be responsible for communicating with liaison and maintaining the relationship between principal investigator, investigator, auxiliary department, clinical institution and other parties;

2. Be responsible for submitting the ethics of center/sub-center, obtaining ethical approval letter, coordinating and holding the sub-center kick-off meeting, and training investigators;

3. Assist PM in the comprehensive monitoring management in clinical trials, perform monitoring according to the requirements of GCP and company SOP and complete the quality assurance on time, timely submit the monitoring report truly reflecting the trial (including the situation of the center, trial progress and quality, completion of case report form, use of investigational drugs, adverse events and serious adverse events, completion of original data and other aspects);

4. Be responsible for the follow-up of clinical trial progress, document management, complete the initiation, implementation and end of the trial according to the timetable requirements;

5. Participate in the screening of clinical study sites and investigators, participate in protocol seminars, participate in clinical trial data (investigator's brochure, trial protocol, informed consent form, case report form, subject diary, etc.) discussion and development;

6. Be responsible for managing the investigator, and be able to fully communicate with the investigator, jointly negotiate and properly solve the problems to ensure that the data are true, accurate and complete;

7. Carry out the work under the guidance of PM, and report the work to the project manager;

8. Complete other temporary work assigned by the superior.

Requirements for appointment:

1. Clinical medicine.Pharmacy or other medical-related specialties, bachelor degree or above;

2. 2 years of working experience in drug clinical trials or above, including CRA, CRC and CTA;

3. Be familiar with the Provisions for Drug Registration and GCP and other clinical trial-related regulations;

4. Have good English reading and writing and oral language ability, reaching CET6 level;

5. Have good interpersonal relationship and good communication and language expression ability;

6. Be good at thinking.Good at summarizing, can suffer and can adapt to frequent business trips.

Main post responsibilities:

Work place: Suzhou 

Rresponsibilities:

1. Be responsible for the review, distribution, archiving and archiving of the company 's quality system (including preclinical study GLP, clinical study GCP and production GMP) documents to ensure that the above processes and results meet the company' s requirements;

2. Be responsible for the distribution, collection, archiving and collation of the company 's R & D quality system-related records;

3. Be responsible for the archiving collection and collation of the company' s paper R & D archives (study protocol, records and reports, etc.);

4. Be responsible for the archiving collection and collation of the company 's electronic R & D archives (study protocol, records and reports, etc.);

5. Be responsible for the daily management of the company' s archives;

6. Assist in completing the management of supplier 's collaborative archives;

7. Complete other work assigned by the superior authorities.

Requirements for appointment:

1. Pharmacy and related specialties are preferred, college degree or above;

2. Familiar with the quality system document control process (GCP, GLP or GMP), with more than 1 year of work experience in related fields;

3. Familiar with drug R & D-related GCP, GLP, GMP or ISO9000 and other quality management systems, skilled operation of office management software;

4. Patience, meticulous, but not stereotyped.