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