Clinical Trial Assistant-CTA

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were 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 applicableand 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