Clinical Trials Administrator

1 month ago

Beijing, Beijing, China BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Full time
Job Summary

We are seeking a highly organized and detail-oriented Clinical Trials Administrator to join our team at BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd. As a Clinical Trials Administrator, you will play a critical role in the success of our clinical trials by providing administrative support to our project teams.

Key Responsibilities
  • Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support
  • Assist in the preparation of study and site-specific materials in accordance with relevant SOPs
  • Complete minute-taking and documentation for sponsor/external or internal teleconferences as requested
  • Assist in setting up and maintaining tracking systems/spreadsheet for e.g. study supplies
  • Maintain the Project Directory
  • Provide support for Investigator Meetings; track meeting attendees and/or other information regarding the Investigator Meeting
  • Provide support to project team (e.g. proof-reading and editing correspondence, mailings, shipping of study files, faxing and photocopying documents, assembling study documents, and arranging meetings, etc.)
  • Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable
  • Audit and CAPA tracking
  • Set up and maintain clinical investigator files and documentation
  • Liaise with vendors, as needed, for study conduct such as printing study materials and/or external systems access for study team members
  • Coordinate and plan study supply shipments with vendors
  • Maintain and confirm shipment information such as courier tracking numbers and date of shipping and delivery
  • Prepare/assemble/ship supplies to sites pre-SIV: Study File Notebooks, CRFs, other study-specific ancillary supplies (i.e. diary cards, patient visit reminders)
  • Generate reports as needed, for example CTMS site contact information list
  • Work with the In-House CRA and other project team members on reconciliation of data with CTMS
  • General communications to sponsors, sites and internal team members via electronic mail or courier or telephone
  • Perform other administrative duties as assigned by Line Manager, Project Managers or Clinical Trial Lead
Requirements
  • Minimum one (1) year administrative experience or equivalent training
  • Good oral and written communication skills
  • Good organizational and time management skills
  • Computer literacy (Microsoft Office Suite (Word, Excel, PowerPoint)
  • Aptitude for handling and proof-reading numerical data, some spreadsheet software competency
  • Good typing skills
  • Good spelling and proof-reading skills
  • Ability to operate standard office equipment (e.g., fax, copier)
  • Works efficiently and effectively in a matrix environment
  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate
  • Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements
  • Thorough knowledge of monitoring procedures
  • Basic understanding of the clinical trial process
Preferred Qualifications
  • Valid Driver's License

At BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd, we are committed to revolutionizing the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. We are seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. If you are a detail-oriented and organized individual with a passion for clinical trials, we encourage you to apply for this exciting opportunity.

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