Job Description
Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department mentorship document. Provides administrative support for site activation activities. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations. Represents CRG personnel. May apply local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. May act as a buddy during onboarding and provide training to new staff as needed.
Essential Functions
1. Coordinate, oversee, and complete functions on assigned trial activities as detailed on the task matrix, according to the specific role (Central or Local).
2. Perform department, Internal, Country, and Investigator file reviews as assigned, and document findings in appropriate systems.
3. Ensure tasks are performed on time, within budget, and to high-quality standards. Proactively communicate risks to project leads.
4. Provide system support (e.g., Activate & eTMF) and ensure system databases are current.
5. Perform administrative tasks on assigned trials, including processing documents sent to Client (e)TMF, performing (e)TMF reviews, distributing mass mailings, and providing documents and reports to team members.
6. Analyze and reconcile study metrics and findings reports. Assist with clarification and resolution of findings related to site documentation.
7. Assist with coordination, compilation, and distribution of Investigator Site File (ISF), Pharmacy binder materials, and non-clinical study supplies to sites.
8. Assist with study-specific translation materials and translation QC upon request.
9. Maintain knowledge of and understand SOPs, client SOPs/directives, and current regulatory guidelines relevant to services provided.
10. Conduct on-site feasibility visits where applicable (Asia Pac only).
11. Support scheduling of client and internal meetings as needed.
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