Remote Start-Up & Regulatory Specialist I

IQVIA Inc; United States; Remote; USD 30,000 - 41,000; Full time

Benefits offered by this job

Remote work

Job summary

IQVIA is seeking a Regulatory & Start Up Specialist 1, cFSP for a Mexico-based, fully home-based role. The incumbent will proactively drive start-up and maintenance activities for assigned studies and sites, acting as SPOC for sites, SAMs, and project teams in alignment with SOPs and timelines.

Responsibilities include regulatory document preparation and review, tracking progress, providing local expertise, and coordinating with sponsors as needed.

Qualifications

• Bachelor degree in life sciences.
• 1+ years of clinical research experience and startup management experience.
• Fluent English (written and oral).

Responsibilities

• Serve as Single Point of Contact (SPOC) for sites, SAM, PM and other departments; ensure SOP/WI adherence and timelines.
• Perform startup and site activation activities per regulations, SOPs, and work instructions; distribute documents to sites and team.
• Prepare site regulatory documents for completeness and accuracy.
• Maintain internal systems, databases and tracking tools with project data.
• Review site performance metrics and provide feedback to management.
• Establish and agree on project planning and timelines; implement contingency plans as needed.
• Inform team on completion of regulatory and contractual documents for sites.
• Track and follow up on regulatory, ethics, ICF, and IP release documents per timelines.
• Provide local regulatory expertise to SAMs and project team during planning.
• Quality control documents provided by sites.

Skills

Fluent English

Analytical thinking

Interpersonal skills

Multitasking

Education

Bachelor's degree in life sciences

Job description

IQVIA is seeking a Regulatory & Start Up Specialist 1, cFSP for a Mexico-based, fully home-based role. The incumbent will proactively drive start-up and maintenance activities for assigned studies and sites, acting as SPOC for sites, SAMs, and project teams in alignment with SOPs and timelines.

Responsibilities include regulatory document preparation and review, tracking progress, providing local expertise, and coordinating with sponsors as needed.