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