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Senior Clinical Trial Assistant (FSP)

Parexel International Corporation

China - Any Region - Home Based

Role Summary: To provide administrative, technical and logistical support to ensure timely and efficient execution of clinical trials, and compliance of ICH-GCP, SOP, and regulatory regulations.Organizational Relationships: Reports to Clinical Trial Assistant Lead.Partners with study level roles, such as Study Mangers(SM), Clinical Research Associate (CRA), and project level roles as necessary.Partner with enabling functions as applicable.Responsibilities: Major Duties of CTA:Support the tasks below for assigned project throughout the study:o Requests payments in ACM/Ariba for study related costo Updates the trial and site information as necessary in Corporate Clinical Trial Registry (CCTR) in a timely mannero Attends appropriate training programs and project teleconferences as applicable.o Maintains the study status tracking and provides analysis report to Study Manager.o Assists Study 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.Study Start-Upo 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Study Conducto 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.Study Close-Outo Ensures along with the CRA the reconciliation of Trial Master File and the Site Master Fileo Supports SM and CRA for final archive of study-related documentso Ensures study payment completion.Other responsibilities of the CTA:o Supports SMs/CTA lead for quality improve related initiativeso Assists in preparation of newsletters and other study-related documents.o Complies with Pfizer Policies, SOPs & IGs and local regulations during various projects related transactionso Takes SME role and provides training to CRA/SM regularly.o Ensures P2L and QCB Metrics Compliance pertaining to CTA role.o Provides back-up coverage for other CTAs as necessary.o Mentors new CTA when applicable (apply for B4 level)o Supports CTA Lead for production and tracking of trial metrics measurements.o Supports SM for coordinating with sites for finalizing budget worksheets and contractual agreements (e.g. FCPA clauses).o Maintains and ensures the availability of inventory for all non drug supplies.o Provides logistic and administrative support to project teams.o Assists on SUSAR package preparation for ethics Committee and regulatory authority, if applicableDemonstrates and promotes Pfizer global value system across all interactions.QualificationsQualifications (Training, Education and Prior Experience)

College degree or above, University Graduate preferred

Science Background preferred

Good English skills in writing and reading

Proficiency in basic computer literacy (e.g. Microsoft word, Excel and PowerPoint)

Knowledge of ICH GCP and local regulations preferred

Experience in clinical trial administration preferred

Experience in management of clinical trial and/or regulatory documents preferred

Knowledge of application used in the clinical trials preferred

Job posted: 2022-03-12

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