Clinical Trial Assistant

**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 and Unexpected Serious Adverse Reaction (SUSAR), paper Case Report 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-GCPs and other applicable requirements   **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