operations
Posted 2 days agoSite Navigator II (Clinical Logistics - CASS)
at Fortrea
On-site
Responsibilities
- Perform and coordinate label review and country translations according to set procedures.
- Develop project specific plans for the Clinical and Ancillary supply component of assigned studies.
- Review the protocol to confirm if Fortrea/ other vendor can import all the supplies required in the region.
- Coordinate and track shipments to sites required for each protocol as appropriate in the region.
- Update the Importation Process for the region(s) as needed.
- Perform administrative tasks required during study start up activities (e.g., word processing, assembly of study documents, mass mailings, filing, faxing/photocopying).
- Manage the regions drug supply vendor activities as applicable.
- Oversee importation logistics and document exchange to ensure smooth clinical supply transportation arrangements are agreed and set up.
- Develop, review, and approve drug supply labels as applicable.
- Coordinate ancillary supply logistics with various vendors or internal team.
- Independently research and evaluate proposal request from clients in all therapeutic areas within agreed timeframes.
- Conduct QC of documents as required by the process.
- Undertake literature and internet searches as required.
- Mentor other team members.
- Understand and follow, provide input to project specific and Fortrea policies and procedures.
Requirements
- Work with GRS on obtaining, understanding, and interpreting country-specific
- Qualifications (Minimum Required): University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 3 years work
- experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and FDA, GMP regulations.
- In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 5 years work
- experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered. Fortrea may consider relevant and equivalent