Clinical Trial Assistant-CTA (FSP-北京)

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