主要职责

• To assist study teams in the study conduct with powerful logistic support from CMS in accordance with JunShi written standards and ICH GCP.
• Set up country study file binder and site binders before site initiation according to Junshi and study specific requirements; Be responsible to check the validity of archiving format, category of country/site study files before they are archived to central depot.
• Remind CRAs to retrieve all essential documents from site timely; Check and track all study related documents in a timely manner to make sure document integrality;
• Act as Custodian of Filing Room, track, file and archive all clinical study documents for the ongoing and completed studies in accordance with the related SOPs.
• Clinical trial/research outsourcing services support, including supplier selection, communication, quotation and contract management etc.
• Prepare IEC submission dossier according to the requirements of study managers/CRAs before site initiation and during the study ongoing period; Coordinate CRAs to submit documents within the required timeline and follow the approval letter up. Prepare and provide the standard study index and folds for all the study sites; Copy IEC submission materials and convey them to each IEC.
• Coordinate study documents printing, copying, scanning, fax, mail or email and stamp according to the requirements of project managers/CRAs.
• Study specific facility purchasing (e.g.: fax machine, cabinet, computer etc.); Track each equipment, paper CRFs and other study supplies which provided to sites; Coordinate every shipment of specimen with Courier to make sure the study required condition is met.
• Coordinate PM for logistic arrangement of Investigator Meeting, Project Meeting including meeting budget estimation, suitable travel agency and meeting location selection to fulfill the requirements by study team and company policy; Arrange the meeting logistic things with the help from travel agency (Visa application, flight and hotel arrangement, etc.); Prepare meeting binders and other facilitate tools ; Verify the invoice against original receipt breakdown to ensure fulfilling with the company policy and code of conduct etc.
• Distribute and track SAE report to Investigators in a timely manner according to JunShi SOPs and ICH GCP requirements; Distribute particular letters, such as “Dear Investigator Letter”, newsletter to Investigators/IECs for their notification.
• Assist DM team to maintain the EDC account for Investigators and other ad hoc users.
• As a drug coordinator, provide the necessary coordination in the IMP application and distribution.
• Regularly confirm the drug batch and supply quantity with PM.
• Perform other tasks assigned by line manager and study specific tasks assigned by PM.

基本要求和优先条件

Basic Requirements:

• Bachelor’s degree. Medical major preferred.
• >2 years’ pharmaceutical industry experience with 1-2 years’ strong experience in clinical research.
• Good communication with study team, vendors. Coordination and organization skills.
• Good analytical and problem solving skill
• Prefer to have good command of English in speaking, listening, reading and writing
• Familiar with IT software e.g. Microsoft Word, Excel

Preferred Requirements

• Be familiar with finance.
• Be Familiar with Good Clinical Practice and relevant local regulations.

上班地址：世纪汇