Site Activation & Regulatory Specialist

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

Job summary

IQVIA in the United States is seeking a Site Activation Specialist to drive country-level SA activities in accordance with SOPs, regulatory standards, and project requirements. You will collaborate with sites, Site Activation Managers, and the project management team to ensure timely activation and compliant documentation.

The role emphasizes startup activities, regulatory document preparation, data tracking, and performance reviews, with a focus on adherence to timelines.

Qualifications

• Minimum 1 year of clinical research experience.
• Equivalent combination of education, training and experience may be considered.

Responsibilities

• Serve as SPOC for investigative sites and project teams, ensuring SOP/WI compliance.
• Perform start-up and site activation activities per regulations and SOPs.
• Prepare site regulatory documents for completeness and accuracy.
• Maintain internal systems with project-specific data and tracking tools.
• Review site performance metrics and provide feedback to management.
• Coordinate project timelines and ensure contingency planning is in place.
• Provide local expertise to SAMs during planning and execution.
• Quality control documents provided by sites.
• May have direct contact with sponsors on initiatives.

Skills

Clinical research experience

Job description

IQVIA in the United States is seeking a Site Activation Specialist to drive country-level SA activities in accordance with SOPs, regulatory standards, and project requirements. You will collaborate with sites, Site Activation Managers, and the project management team to ensure timely activation and compliant documentation.

The role emphasizes startup activities, regulatory document preparation, data tracking, and performance reviews, with a focus on adherence to timelines.