Senior Clinical Trial Assistant (FSP)

Primary Responsibilities:Major Duties of CTASupport the tasks below for assigned project throughout the study:Request payments in Ariba Category Management (ACM)/ Ariba for study related costUpdate the trial and site information as necessary in Corporate Clinical Trial Registry (CCTR) in atimely mannerAttend appropriate training programs and project teleconferences as applicableMaintain the study status tracking and provides analysis report to Study Manager (SM).Assist SM on study budget control by timely tracking and reporting of actual cost and forecastdrafting.Coordinate Clinical Study Agreement approval to ensure site initiation on time.Study Start-UpSupport and coordinate the clinical trial application for amendment and progress report to ethicscommittee and regulatory authority, if applicable, and obtain approval within required timeline.Coordinate and apply for export/ import license of, lab kits, equipment, and specimen, if applicable.Support for preparations of site initiation packages (e.g. Site Master File (SMF))Organize investigator meetingStudy ConductSupport and coordinate the clinical trial application for amendment and progress report to ethicscommittee and regulatory authority, if applicable, and obtain approval within required timeline.Maintain/ develop local tracking spreadsheets for study-related documents, data, tasks, andactivities, as applicable.Assist Clinical Research Associate (CRA) for the responsibility of tracking, distribution and filling ofclinical trial documents/ information (eg. Suspected and Unexpected Serious Adverse Reaction(SUSAR), paper Case Report Forms (CRFs), DCFs) with quality review for accuracy and completeness.

Other responsibilities of the CTASupport SMs/ CTA Lead for quality improve related initiativesAssist in preparation of newsletters and other study-related documents.Comply with client Policies, SOPs & IGs and local regulations during various projects relatedtransactions.Take Subject Matter Expert (SME) role and provides training to CRA/ SM regularly.Ensure P2L and QCB Metrics Compliance pertaining to CTA role.Provide back-up coverage for other CTAs as necessary.Mentor new CTA when applicable (apply for B4 level)Support CTA lead for production and tracking of trial metrics measurements.Support SM for coordinating with sites for finalizing budget worksheets and contractual agreements (e.g. FCPA clauses).Maintain and ensure the availability of inventory for all non-drug supplies.Provide logistic and administrative support to project teams.Assist on SUSAR package preparation for Ethics Committee and regulatory authority, if applicable.Demonstrate and promote Client global value system across all interationsComplete assigned training, including general training requirements, Policies, Standard OperatingProcedures (SOPs), system, and process-related trainingAdhere to applicable Policies, SOPs, and processesDemonstrate commitment to Parexel’s FSP Mission, Vision, and Values, and Parexel’s “We Care” Core Values

Education and Certification:High or secondary School diploma/ certificate or above, University Graduate preferredScience Background preferred

Skills and Experience:Proficiency in basic Computer Literacy (e.g. Microsoft word, Excel and PowerPoint)Knowledge of ICH GCP and local regulations preferredExperience in clinical trial administration preferredExperience in management of clinical trial and/ or regulatory documents preferredKnowledge of application used in the clinical trials preferred

Language Skills:Good English skills in writing and readingProficiency in local language

Other Requirements:Position is located in China