职位描述

职位描述： Position Purpose: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 CTA Lead.?Partners with country level roles, such as Study Mangers(SM), Clinical Research Associate (CRA), Managers of Study Mangers ( SML)and Managers of CRAs (ML), Clinical Quality Lead (CQL), and global level roles as necessary.?Supports global team for China Region Study in setup as needed, such as regional investigator meeting organization, PTMF sytem support, etc.?Partner with enabling functions as applicable.Primary Duties (fundamental components of role—both strategic & operational):Major Duties of CTA:?Support the tasks below for assigned project throughout the study:oResponsible for Trial Master File (TMF)/PTMF maintenance in accordance with ICH-GCP and SOPs (ELARA scanning, indexing and QC within prescribed timelines)oUpdates 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.oMaintains the study status tracking and provides analysis report to Study Manager.oAassits Study Manager on study budget control by timely tracking and reporting of actual cost and forecast drafting.oCoordinates Clinical Study Agreement approval to ensure site initiation on time.?Study Start-UpoSupports and coordinates the clinical trial application to ethics committee and regulatory authority, if applicable, to obtain approval within required timeline.oCoordinates and applies for export/import license of, lab kits, equipments, and specimen, if applicable.oAssists on the preparation, compilation, accuracy review and correction of Investigator Initiation Package (IIP) documents and obtaining approval(s) to ensure drug release in the defined timelines.oSupports for preparation of site initiation packages (e.g. SMF)oOrganizes investigator meeting in country/regional baseoAssists Study Manager on PTMF SSDL setup through communication with global study owner as necessary.?Study ConductoSupports 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.oEnsures along with the CRA the reconciliation of Trial Master File and the Site Master File on a periodic basis.oMaintains / develops local tracking spreadsheets for study-related documents, data, tasks and activities, as applicable.oAssists CRA for the responsibility of tracking, distribution and filing of clinical trial documents/information (e.g. paper CRFs, DCFs ) with quality review for accuracy and completeness.?Study Close-OutoEnsures along with the CRA the reconciliation of Trial Master File and the Site Master FileoSupports SM and CRA for final archive of study-related documentsoEnsures study payment completion.Other responsibilities of the CTA:oSupports CQL for quality improve related initiativesoAssists in preparation of newsletters and other study-related documents.oComplies with Pfizer Policies, SOPs & IGs and local regulations during various projects related transactionsoTakes SME role and provides training to CRA / SM regularly.oEnsures P2L and GCOLT Metrics Compliance pertaining to CTA role.oProvides back-up coverage for other CTAs as necessary.oMentors new CTA when applicable (apply for B4 level)oSupports CTA Lead for production and tracking of trial metrics measurements.oSupports SM for coordinating with sites for finalizing budget worksheets and contractual agreements (e.g. FCPA clauses).oMaintains and ensures the availability of inventory for all non drug supplies.oProvides logistic and administrative support to project teams.oAssists on SUSAR package preparation for Ethics Committee and regulatory authority, if applicableoDemonstrates and promotes Pfizer global value system across all interactions.Training & EducationRequired:?College degree or above?Good English skills in writing and reading?Proficiency in basic computer literacy (e.g. Microsoft word, Excel and PowerPoint)?3 years of clinical research experience(apply for B4 level)Preferred:?Science Background?University Graduate?Experience in clinical trial administrationTraining and Relevant ExperiencePreferred?Knowledge of ICH GCP and local regulations?Experience in management of clinical trial and/or regulatory documents?Knowledge of application used in the clinical trials 职能类别： 临床研究员

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