Parexel

Clinical Trial Assistant

China · Work style not stated · Full time

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About the role

Description from the employer’s posting. Check the employer’s page for the current version.

  • EmployerParexel
  • LocationChina
  • Work styleWork style not stated
  • Employment typeFull time
  • Employer posted

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
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  • 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

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At a glance

  • Employment typeFull time
  • Employer posted
  • Added to ROLIVA
  • Last checked

Skills in this posting

Skills ROLIVA found in the employer’s own description above. A mention is not a requirement.

Excel GCP

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