Site Activation Specialist — Study Start-Up Expert

IQVIA; Durham (NC); On-site; USD 48,000 - 123,000; Full time

Job summary

IQVIA, a leading global provider of clinical research services, is seeking a Site Activation Specialist to coordinate country-level SA activities and ensure compliance with applicable regulations and SOPs. You will serve as the SPOC for sites, SAMs, and project teams, driving timely regulatory deliverables and maintaining quality control.

The role involves startup and activation activities, regulatory document preparation, and ongoing data tracking.

Qualifications

• 1 year of clinical research experience.
• Site activation US and CAN ICF review experience required.
• Experience adapting country ICF for US/Canada regulatory requirements preferred.
• Experience reviewing informed consent elements via checklists and ICF/IP release documents.

Responsibilities

• Act as SPOC for sites, SAM, PM team and other departments to ensure SOP compliance and timelines.
• Conduct startup and site activation activities per regulations and SOPs, distributing documents to sites and team.
• Prepare site regulatory documents and review for completeness and accuracy.
• Maintain internal systems and project tracking tools with site information.
• Provide feedback on site performance metrics and project planning timelines.

Skills

Clinical research experience

Job description

IQVIA, a leading global provider of clinical research services, is seeking a Site Activation Specialist to coordinate country-level SA activities and ensure compliance with applicable regulations and SOPs. You will serve as the SPOC for sites, SAMs, and project teams, driving timely regulatory deliverables and maintaining quality control.

The role involves startup and activation activities, regulatory document preparation, and ongoing data tracking.