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  

岗位要求：

CTA1-2年以上经验

对TMF上传熟练

对英文系统使用比较熟练

对SUSAR递交的流程比较熟练