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Clinical Trial Assistant (FSP) - Wuhan

Parexel

Role overview

Responsibilities

  • Set up and maintain the site level TMF/cTMF, coordinate on document collection, uploading into SharePoint (SP)eTMF, check document completeness, and provide TMF/eTMF quality control (QC) if required
  • Coordinate on EC submission dossier, site start-up preparation, and EC fee application and tracking
  • Collect and update study trackers/metrics report for site level if needed
  • Assist in contract signature process; assist in site level payment initiative and payment and invoice tracking
  • Distribute site materials and equipment, document printing, shipment, and other administrative work
  • Provide business and department office administration support if required
  • Undertake other reasonably related duties as may be assigned from time to time, as appropriate for level of experience

Key facts

  • Remote from: China
  • Full time
  • English

Hard skills

Other skills

  • Communication
  • Teamwork
  • Time Management

About the company

Parexel logo

Parexel

Contract Research Organizations (CRO)

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company details

Company typeXLarge
IndustryContract Research Organizations (CRO)
Company size10001

Links

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Job 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 Role and Responsibilities Summary: 

  • TMF: Set up and maintain the site level TMF/cTMF, coordinate on document collection, uploading into SharePoint (SP)eTMF, check the document completeness, and provide TMF/eTMF quality control (QC) if required. 
  • EC Submission: Coordinate on EC submission dossier, site start-up preparation, and EC fee application and tracking.  
  • Process protocol amendments may include ICF updates. 
  • Tracker/Metrics Report: Collect and update study trackers/metrics report for site level if needed. 
  • Site Contract and Payment: Assist in contract signature process; assist in site level payment initiative and payment and invoice tracking. 
  • Site Materials and Equipment: Distribute site materials and equipment, document printing, shipment, and other administrative work. 
  • Administrative: Business and department office administration support if required. 
  • To undertake other reasonably related duties as may be assigned from time to time, as appropriate for level of experience 

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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