other
Posted 9 hours agoFSP Clin Trials Admin I (Guangzhou)
at Fortrea
Shanghai, ChinaOn-site
Responsibilities
- Maintain the Project Directory.
- Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable.
- Set up and maintain clinical investigator files and documentation.
- 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.
- Perform other administrative duties as assigned by Line Manager, Project Managers or Clinical Trial Lead.
- Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support.
Requirements
- The degree of responsibility given to the CTA shall reflect their experience, and level of contribution which they can make to the project.
- Qualifications (Minimum Required): Diploma – Associate degree or equivalent. In lieu of the above requirement, candidates with 1-2 or more years of relevant Clinical Research
- experience in pharmaceutical or CRO industries may be considered. Fortrea may consider relevant and equivalent
- experience in lieu of educational requirements. Speaking English and local language. Writing/Reading English and local language.
- Experience (Minimum Required): Minimum one (I) year administrative experience or equivalent training.
- Computer literacy (Microsoft Office Suite (Word, Excel, PowerPoint).
- Aptitude for handling and proof-reading numerical data, some spreadsheet software competency. Good typing skills.
- Ability to operate standard office equipment (e.g., fax, copier).
Additional details
- This role is for upcoming future opportunities that may arise at Fortrea.
- Fortrea is excited to connect with talented individuals for future opportunities.
- If you meet the job requirements, we'll invite you for an interview.
- If you're pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your interest before moving forward with an offer.
- Job Overview: The Clinical Trial Administrator (CTA) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project.
- The CTA performs study-related tasks as required by the department, including (but not limited to): communicate with project team members regarding study updates, maintain documentation as required by protocols, SOPs and regulatory standards, to ensure timely production of high quality clinical data, provide systems support, track information related to the status of study activities and assist with general administrative functions as required.
- Activities will be conducted in compliance with Company or Sponsor SOPs and regulatory standards and guidelines applicable. Summary of
- 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/spreadsheets for e.g., study supplies.