湖州招聘

Responsibilities:
Part I: Project Team Leadership and Management (if assigned)
(1) Planning
? Planning of project activities and study timelines based on project goal and sponsor's expectation.
(2) Implementation
? Organize and Lead meeting/teleconferences for study activities implementation (e.g. investigator meeting, project review meeting etc), monitoring the progress of each CRA responsible sites, and assessing overall status of the project.
? Develop the project management plan, monitoring plan etc as required for the study.
? Develop study specific tools/forms, study templates as required for the study.
? Develop and manage project budget.
? Order and ensure all clinical supplies (including drug and non-drug) are adequate for all sites throughout the study period.
? Ensure all team members have timely access to appropriate systems and tools, if applicable (e.g.IVRS, eCRF etc)
? Organize and conduct site feasibility visits according to guidelines and make recommendation for final approval.
? Coordinate the application of specimen export permit, if applicable.
? Maintain and manage all project trial master files throughout the study period and coordinate the long term archiving and handover to sponsor at the end of the study.
? Conduct the co-visit at site with CRA according to company's SOP
(3) Tracking
? Track study progress and ensure project is conducted according to the plan.
(4) Communication
? Communicate to monitors new study information, study timelines and goals, study requirements.
? Responsible for raising overall project specific issues to management (e.g. Project Director, Senior Management).
? Submit the weekly project report to management (e.g. Project Director, Senior Management).
? Communicate to sponsor study status and key issues
? Generate monthly project status report to sponsor.

Part II: Study Implementation
(1) Monitoring
?
-Monitoring
? Perform pre-study visit to ensure the site has adequate resources for the study.
? Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined
in protocol, SOP and ICH-GCP.
? Track study recruitment to ensure recruitment target is achieved in all studies.
? Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete
monitoring visit report in a timely manner Coordinating
? Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for
start-up and throughout the study.
? Assemble site specific EC submission dossier, and ensure submission to EC.
?
-Training
? Provide ongoing training to site staff with regards to ICH-GCP, study protocol and requirements.
? Conduct site initiation to ensure that the site has a thorough understanding of the study protocol
and requirements.
? Documentation
? Collect essential documents at study start-up, during and at study close-down. Maintain and
update these documents in investigator files, trial master files.
? Prepare/Pack for archiving at the end of the study.
(2) Drug Safety
? Ensure safety information is disseminated to all sites according SOP and applicable regulations.
? Report SAE promptly according to SOPs and applicable regulations.
(3) Finance and Administration
? Finalize budget and obtain signed contract from site, prior to site initiation visit.
? Ensure Study Payment Schedule is executed and retain relevant documents/receipts.
(4) Study Tools and system
? Update and maintain Study tools/systems in a timely manner.

What do you need?
(a) Academic / Major
Bachelor degree in biomedical/science discipline or equivalent (e.g. medical, Nurse , Pharmacology)
(b) Professional Skills
Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/
procedures
Good working and proactive attitude
Value importance of teamwork
(c) Working Experience
At least 1 years of relevant working experiences
Experience of CRA experiences (preferred)
(d) Language ability
Good command of written and verbal English
(e) Computer Literacy
Good skills on Microsoft Word, Excel, PPT and Outlook, etc
(f) Others
Knowledge and/or experience in medical practice is a plus.

上海人才有限公司诚聘