CTC, level I

As a CTC, you will provide administrative and technical support to the Project Team. Support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provide administrative support for site activation activities. Aid the development of the critical path for site activation within assigned projects in support of rapid site activations.

A day in the Life:
According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
Assists with study-specific translation materials and translation QC upon request.
Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Where applicable, conducts on-site feasibility visits (APAC only).
May support scheduling of client and/or internal meetings.
May review and track of local regulatory documents.
May provide system support (i.e., Activate & eTMF).
May support RBM activities.