Clinical Trial Assistant_ Digital

**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