An initiation Clinical Research Associate (iCRA) specializing in Pre SIV and Activation tasks will be assigned & accountable for managing and driving the strategy for the startup, Pre SIV and Activation tasks of the study. The iCRA also supports submission and approval process for the protocol amendments if applicable. In Japan for studies that are using Parexel SOPs, prior to SIV the iCRA will be responsible for preparing the initial site related IRB application and associated documents required prior to SIV as delegated by CRA and reviewing and approving all essential documents (SRP/Site Greenlight, ICF, etc.). Post SIV the iCRA would review / approve the documents as determined by Parexel SOPs (e.g., SRP/Site Greenlight & ICF). For studies that use client SOPs, the necessity for the iCRA role will depend on the contracted tasks/procedures; if the iCRA role is not required the CRA will cover all tasks necessary.
Key Accountabilities
Start-up (from site identification through site activation):
Act as Parexel’s direct point of contact with assigned sites,
accountable for quality and delivery during the start-up phase.
- Build relationships with investigators and site staff.
- Support on request country specific feasibility and/or site pre-qualification and qualification activities, which may include:
- Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA) and any amendments.
- May conduct remote Qualification Visits (QVs).
- Liaison with stakeholders to understand Clinical Site Agreements (CSA) timelines.
- Manage country and site level TMF issues ensuring documents’ First Time Quality (FTQ) as well as providing direct resolution to reported site problems.
- Develop strategy to configure, distribute, collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (Site SIV Readiness/Greenlight Documents) and any updated or amended regulatory documentation.
- Custom