Clinical Trial Assistant_ Digital (FSP)
Parexel · Beijing
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
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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[1]
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