Clinical Trial Assistant (FSP)

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