Experience

QPS Holdings, LLC

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Study Start-UP assistant

  • Sep 2022 - Present

  - Prepare the documents for initial/interim report/amendment/final submission according to TFDA/IRB/REC regulations and/or SOPs and work instructions. - Review and prepare the site contracts and budget and negotiate with sites, clinical trial centers and study teams. - Collect study required information and document to plan submission strategy and timeline. - Develop the informed consent form or to generate the ICF from adaption of Sponsor provided global ICF according to required regulatory and/or applicable SOPs - Prepare the submission document according to TFDA/IRB/REC regulations and/or appropriate SOPs. - Review /verify the translated study document of trials. - Collect investigational staff required signature pages & qualified GCP/ethical certificates. - Follow up RA/IRB/REC, and update the submission timeline and status. - Prepare RA/IRB/REC comment reply and re-estimate submission timeline. - Discuss with LM/PM/Sponsor or other departments to resolve submission related issues. - Work with Sponsor/PM or other departments to complete the submission under a good quality under GCP and required SOPs. Show less



QPS Holdings, LLC

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Study Start-UP assistant

  • Jun 2018 - Oct 2021

  - File and archive the study document and check the accuracy. - Contact the translation vendor and arrange the document translation. - Review and verify the translated study document for the assigned project. - Collect investigational staff qualified GCP/ethical certificates. - Collect the submission required information and document for the assigned projects. - Prepare the interim report submission and get IRB renew approval. - Follow up and update the submission status for the assigned project. - Prepare RA/IRB/REC comment reply and re-estimate submission timeline if needed. - To support the administrative work like but not limit to >Document copy, scan, destruction, mail routine, courier. >Manage the stationery and copy machine. >Assist the project payment application. Show less