- Support the tasks below for assigned project throughout the study:
- Study Start-Up
- Study Conduct
- Study Close-Out
-
Clinical Research Associate(FSP)
发现在: beBee S2 HK - 2天前
Parexel Kowloon, 香港 Local OfficeJob DescriptionKey Accountabilities: · Start-up (from site identification through pre-initiation: · Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase. · Build relationships with investigators and site staf ...
Clinical Trial Assistant - Kowloon, 香港 - Parexel
发现在: beBee S2 HK - 3天前
描述
Major Duties of CTA:
o Updates the trial and site information as necessary in Corporate Clinical Trial Registry (CCTR) in a timely manner
o Attends appropriate training programs and project teleconferences as applicable.
o Maintains the study status tracking and provides analysis report to Project Manager.
o Assists Project Manager on study budget control by timely tracking and reporting of actual cost and forecast drafting.
o Coordinates Clinical Study Agreement approval to ensure site initiation on time.
o Supports and coordinates the clinical trial application to ethics committee and regulatory authority, if applicable, to obtain approval within required timeline.
o Coordinates and applies for export/import license of, lab kits, equipments, and specimen, if applicable.o Supports for preparation of site initiation packages (e.g. SMF)
o Organizes investigator meeting
o Supports and coordinates the clinical trial application for amendment and progress report to ethics committee and regulatory authority, if applicable, and obtain approval within required timeline.
o Maintains / develops local tracking spreadsheets for study-related documents, data, tasks and activities, as applicable.o Assists CRA for the responsibility of tracking, distribution and filing of clinical trial documents/information (e.g. SUSAR, paper CRFs, DCFs ) with quality review for accuracy and completeness.
o Supports SM and CRA for final archive of study-related documents
o Ensures study payment completion.