Clinical Trial Operations Specialist

6 days ago


Raleigh, North Carolina, United States Advanced Recruiting Partners Full time
Job Description

We are seeking a highly skilled Clinical Trial Operations Specialist to join our team at Advanced Recruiting Partners. As a key member of our clinical operations team, you will be responsible for ensuring the smooth execution of clinical trials from start-up to close-out.

The ideal candidate will have a strong background in clinical trial management, with experience in developing TMF plans, conducting quality checks, and providing feedback to ensure correctness and completeness of documents and trial data.

You will also be responsible for setting up studies in our Clinical Trial Management System (CTMS), ensuring data fields are up-to-date, and performing quality checks on CTMS. Additionally, you will liaison between partners, CPM, study physicians, and legal teams to resolve local informed consent questions and ensure fast resolution.

Responsibilities
  • Develop TMF plans and conduct ongoing and final QC checks of TMF sections owned by CPM
  • Provide support for setting up studies in CTMS and ensure data fields are up-to-date
  • Conduct ongoing and final QC checks of CTMS and liaise with partners/CPM to provide feedback and ensure resolution of issues
  • Liaise between partners, CPM, study physicians, and legal teams to resolve local informed consent questions
  • Check company Data Standard COA Repository and liaise with CPM to identify vendors and obtain licensing agreements


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