Select research institutions and investigators that meet clinical study requirements and conduct qualification assessments;
Establish close relationships with investigators, and communicate and coordinate with research institutions;
Deliver work plans for the launch, inspection and termination of clinical trials in accordance with the requirements of the company’s SOPs;
Independently prepare documents to be submitted to the project approval authority, the Ethics Committee and China Human Genetic Resources Management Office, and submit applications to the administering authority in accordance with the requirements of the project group;
Independently organize and undertake the launch of clinical trial at various research institutions and deliver reports in a timely manner;
Serve as the main contact for the clinical study team and undertake the communication, correspondence and related documents of the designated projects;
Responsible for the negotiation, signing and execution of the clinical trial agreements with research institutions and make payments to charges under such agreements;
Conduct regular inspection of research institutions, including protocol compliance, source data and document review and archival, management and registration of investigational drugs, report preparation, and investigator feedback;
Coordinate and arrange meetings for clinical trial investigators, including protocol discussion meetings and investigator meetings;
Maintain records of study documents and drug recovery, storage, and disposal;
Assist superiors in providing trainings and professional guidance for CRCs and undertake some project management work in clinical trials;
Complete database locking at research institutions.
College education or above, majoring in clinical medicine, pharmacy or other related fields;
3-5 years of working experience/industry experience/position-related experience, preferably with experience in early R&D of new cancer drugs;
Knowledge/Skills: Familiar with GCP and clinical trial-related laws and regulations; familiar with the workflow and job duties of drug clinical trials; have participated in the entire implementation process of one or several devices or clinical trial projects; and familiar with the workflow and job duties of clinical inspection;
Occasional business trips, proactive, good communication skills, and teamwork spirit.
If you are interested in this position, please send your resume to us!
Beijing：renshanghe@sumgenbio.com +86-10-56315401-808 Ms. Ren
Hangzhou/Shanghai：hr@sumgenbio.com +86-571-86837379 Ms. Zhao
Copyright Rm. 301, F3, Building C, Block 2, No. 688, Bin'an Road, Changhe Zhejiang ICP Filing No. 18039044
