Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Summarized Purpose:

Provides administrative and technical support to the Project Team. Supports eTMF filing of documents. 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. Supports training of new staff and participates in departmental initiatives to aid in process improvements/enhancements.

Key responsibilities

• According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
• 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 filing supports, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
• Assists the project team with the preparation of regulatory compliance review packages.
• Provides support as needed to coordinate with internal departments, ensuring site start-tup activities within the site activation critical path are aligned.
• Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.
• Ensures an efficient, effective plan is in place for site contact and follow up. Ensure compliance with the plan and escalate concerns/non-compliance to management.