l Develop study specific tools/forms, study templates as required for the study.

l Develop and manage project budget.

l Organize and conduct site feasibility visits according to guidelines and make recommendation for final approval.

l Coordinate the application of specimen export permit, if applicable.

l 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.

l Conduct the co-visit at site with CRA according to Tigermed SOP

(3) Tracking

l Track study progress and ensure project is conducted according to the plan.

(4) Communication

l Communicate to monitors new study information, study timelines and goals, study requirements.

l Responsible for raising overall project specific issues to management (e.g. Project Director, Senior Management).

l Submit the weekly project report to management (e.g. Project Director, Senior Management).

l Communicate to sponsor study status and key issues

l Generate monthly project status report to sponsor.


Part II: Study Implementation

(1) Monitoring

l Monitoring

n Perform pre-study visit to ensure the site has adequate resources for the study.

n Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP and ICH-GCP.

n Track study recruitment to ensure recruitment target is achieved in all studies.

n Conduct monitoring visit according to SDV plan and SOP； address issues with sites and complete monitoring visit report in a timely manner Coordinating

n Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.

n Assemble site specific EC submission dossier, and ensure submission to EC.

l Training

n Provide ongoing training to site staff with regards to ICH-GCP, study protocol and requirements.

n Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.

l Documentation

n Collect essential documents at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files.

n Prepare/Pack for archiving at the end of the study.

(2) Drug Safety

l Ensure safety information is disseminated to all sites according SOP and applicable regulations.

l Report SAE promptly according to SOPs and applicable regulations.

(3) Finance and Administration

l Finalize budget and obtain signed contract from site, prior to site initiation visit.

l Ensure Study Payment Schedule is uted and retain relevant documents/receipts.

(4) Study Tools and system

Update and maintain Study tools/systems in a timely manner.



(a) Academic / Major 学历 /专业

Bachelor degree in biomedical/science discipline or equivalent (e.g. medical, Nurse , Pharmacology)


(b) Professional Skills 专业技能要求

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 工作经验要求

At least 1 years of relevant working experiences

Experience of CRA experiences (preferred)



(d) Language ability 语言能力

Good command of written and verbal English


(e) Computer Literacy 电脑相关知识

Good skills on Microsoft Word, Excel, PPT and Outlook, etc