Clinical Trial Start-Up Contractor (Regulatory)

Tigermed; Georgia; On-site; USD 90,000 - 130,000; Full time

Job summary

Tigermed in the United States (Georgia) seeks a Regulatory Start-Up specialist to support feasibility, regulatory submissions, and site activation for clinical trials. You will liaise with Clinical Monitoring, Site Contracts, Regulatory Affairs, and sponsors to enable rapid trial starts, develop feasibility questionnaires, and coordinate with cross-functional teams to secure client approvals.

The role involves reviewing CDAs, tracking timelines, providing safety and quality assurances, assisting

Responsibilities

• Feasibility: Liaise with Clinical Monitoring, Site Contracts, Regulatory Affairs, other teams and sponsors to enable rapid trial start-up.
• Regulatory activities: Plan, organize, compile, progress, track and submit regulatory submissions timely; review translations and QC dossiers as needed.
• Site Start-up: Manage site activation resources, oversee regulatory requirements, coordinate global staffing plans, and support HR-related tasks within projects.
• Report: Record hours, participate in meetings and trainings, and support project progress communication.

Job description

Tigermed in the United States (Georgia) seeks a Regulatory Start-Up specialist to support feasibility, regulatory submissions, and site activation for clinical trials. You will liaise with Clinical Monitoring, Site Contracts, Regulatory Affairs, and sponsors to enable rapid trial starts, develop feasibility questionnaires, and coordinate with cross-functional teams to secure client approvals.

The role involves reviewing CDAs, tracking timelines, providing safety and quality assurances, assisting