Clinical Trial Assistant_ Digital (FSP)

Job description

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