Parexel

Clinical Trial Assistant_ Digital (FSP)

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

Show full description

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

undefined

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

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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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