Clinical Trial Assistant_ Digital (FSP)

When our values align, there's no limit to what we can achieve.   At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities Project Support - Requests payments in Ariba Category Management (ACM)/ Ariba for study - related cost - Updates the trial and site information as necessary in Corporate Clinical Trial - Registry (CCTR) in a timely manner - Attends appropriate training programs and project teleconferences as - applicable - Maintains the study status tracking and provides analysis report to Study - Manager (SM) - Assists SM on study budget control by timely tracking and reporting of actual - cost and forecast drafting - Coordinates Clinical Study Agreement approval to ensure site initiation on - Time Study Start-Up - 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 - Coordinates and applies for export/ import license of, lab kits, equipment, - and specimen, if applicable - Supports for preparations of site initiation packages (e.g. Site Master File - (SMF)) - Organizes investigator meeting Study Conduct - 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 - Maintains/ develops local tracking spreadsheets for study-related - documents, data, tasks, and activities, as applicable - Assists Clinical Research Associate (CRA) for the responsibility of tracking, - distribution, and filling of clinical trial documents/ information (eg. Suspected - undefined - Forms (CRFs), DCFs) with quality review for accuracy and completeness Other responsibilities of the CTA - Supports SMs/ CTA Lead for quality improve related initiatives - Assists in preparation of newsletters and other study-related documents - Complies with client Policies, SOPs & IGs and local regulations during various projects related transactions - Takes Subject Matter Expert (SME) role and provides training to CRA/ SM regularly - Ensures Metrics Compliance pertaining to CTA role - Provides back-up coverage for other CTAs as necessary - Mentors new CTA when applicable - Supports CTA lead for production and tracking of trial metrics measurements - Supports SM for coordinating with sites for finalizing budget worksheets and contractual agreements - Maintains and ensures the availability of inventory for all non-drug supplies - Provides logistic and administrative support to project teams - Assists on SUSAR package preparation for Ethics Committee and regulatory authority, if applicable Compliance with Parexel standards - Complies with required training curriculum - Completes timesheets accurately as required - Submits expense reports as required - Updates CV as required - Maintains a working knowledge of and comply with Parexel processes, ICH[1] Skills: - Proficiency in basic Computer Literacy (e.g. Microsoft word, Excel and PowerPoint) - Proficient in Chinese, good English skills in writing and reading - Good interpersonal skills, good at communication - A flexible attitude with respect to work assignments and new learning, quickly-learning - Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail - Willingness to work in a matrix environment and to value the importance of teamwork Knowledge and Experience: - Knowledge of ICH GCP and local regulations is preferred - Experience in clinical trial administration is preferred - Experience in management of clinical trial and/ or regulatory documents is preferred - Knowledge of application used in the clinical trials is preferred Education: - Science background is preferred - High or secondary School diploma/ certificate or above, University Graduate is preferred