Clinical Startup & Regulatory Specialist

Regulatory Toolkit; Durham (NC); On-site; USD 48,000 - 157,000; Full time

Job summary

IQVIA, a leader in clinical research services in the United States, seeks a Site Activation specialist to coordinate regulatory tasks at the country level, ensuring compliance with SOPs, WIs, and project timelines.

You will act as SPOC for investigative sites, manage startup activities, review documents, and provide local regulatory expertise to the SAM and project team. A life sciences degree and 3 years of clinical research experience with leadership are required.

Qualifications

• Bachelor's degree in life sciences with 3 years clinical research or related experience.
• Solid knowledge of GCP/ICH and regulatory guidelines.
• Strong negotiation, communication, and interpersonal skills.
• Ability to manage multiple projects and work independently.
• Experience leading projects or teams is a plus.

Responsibilities

• Serve as SPOC for investigative sites, SAM, and project teams to ensure SOPs and timelines.
• Perform startup and activation activities per regulations and SOPs; distribute documents to sites and team.
• Prepare and review site regulatory documents for completeness and accuracy.
• Maintain internal systems and databases with project-specific information.
• Review performance metrics and provide management feedback.
• Monitor timelines and implement contingency plans as needed.
• Inform team of regulatory and contractual document completion for sites.
• Review, track and coordinate document approvals and IP release in line with timelines.
• Provide local regulatory expertise during initial and ongoing project planning.
• Perform quality control of documents provided by sites.
• May interact with sponsors on specific initiatives.

Job description

IQVIA, a leader in clinical research services in the United States, seeks a Site Activation specialist to coordinate regulatory tasks at the country level, ensuring compliance with SOPs, WIs, and project timelines.

You will act as SPOC for investigative sites, manage startup activities, review documents, and provide local regulatory expertise to the SAM and project team. A life sciences degree and 3 years of clinical research experience with leadership are required.