Clinical Trial Assistant_ Digital (FSP)
Description
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
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Requests payments in Ariba Category Management (ACM)/ Ariba for study
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related cost
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Updates the trial and site information as necessary in Corporate Clinical Trial
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Registry (CCTR) in a timely manner
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Attends appropriate training programs and project teleconferences as
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applicable
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Maintains the study status tracking and provides analysis report to Study
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Manager (SM)
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Assists SM on study budget control by timely tracking and reporting of actual
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cost and forecast drafting
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Coordinates Clinical Study Agreement approval to ensure site initiation on
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Time
Study Start-Up
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Supports and coordinates the clinical trial application for amendment and
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progress report to ethics committee and regulatory authority, if applicable,
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and obtain approval within required timeline
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Coordinates and applies for export/ import license of, lab kits, equipment,
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and specimen, if applicable
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Supports for preparations of site initiation packages (e.g. Site Master File
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(SMF))
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Organizes investigator meeting
Study Conduct
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Supports and coordinates the clinical trial application for amendment and
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progress report to ethics committee and regulatory authority, if applicable,
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and obtain approval within required timeline
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Maintains/ develops local tracking spreadsheets for study-related
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documents, data, tasks, and activities, as applicable
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Assists Clinical Research Associate (CRA) for the responsibility of tracking,
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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
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Supports SMs/ CTA Lead for quality improve related initiatives
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Assists in preparation of newsletters and other study-related documents
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Complies with client Policies, SOPs & IGs and local regulations during various projects related transactions
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Takes Subject Matter Expert (SME) role and provides training to CRA/ SM regularly
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Ensures Metrics Compliance pertaining to CTA role
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Provides back-up coverage for other CTAs as necessary
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Mentors new CTA when applicable
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Supports CTA lead for production and tracking of trial metrics measurements
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Supports SM for coordinating with sites for finalizing budget worksheets and contractual agreements
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Maintains and ensures the availability of inventory for all non-drug supplies
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Provides logistic and administrative support to project teams
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Assists on SUSAR package preparation for Ethics Committee and regulatory authority, if applicable
Compliance with Parexel standards
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Complies with required training curriculum
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Completes timesheets accurately as required
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Submits expense reports as required
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Updates CV as required
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Maintains a working knowledge of and comply with Parexel processes, ICH[1]
Skills
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Proficiency in basic Computer Literacy (e.g. Microsoft word, Excel and PowerPoint)
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Proficient in Chinese, good English skills in writing and reading
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Good interpersonal skills, good at communication
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A flexible attitude with respect to work assignments and new learning, quickly-learning
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Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
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Willingness to work in a matrix environment and to value the importance of teamwork
Knowledge and Experience
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Knowledge of ICH GCP and local regulations is preferred
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Experience in clinical trial administration is preferred
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Experience in management of clinical trial and/ or regulatory documents is preferred
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Knowledge of application used in the clinical trials is preferred
Education
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Science background is preferred
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High or secondary School diploma/ certificate or above, University Graduate is preferred