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Clinical Trial Assistant-FSP

Salary undisclosed

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This job is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

  • Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
  • Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.
  • Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
  • Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.
  • Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.
  • Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF "Inspection Readiness".
  • Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.
  • Contributes to the production and maintenance of study documents, ensuring template and version compliance.
This job is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

  • Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
  • Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.
  • Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
  • Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.
  • Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.
  • Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF "Inspection Readiness".
  • Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.
  • Contributes to the production and maintenance of study documents, ensuring template and version compliance.