IQVIA · 1 day ago
Regulatory Start Up Specialist, IQVIA Biotech
Durham, NC
Full-time
Onsite
Entry Level
$46K/yr - $119K/yr
1+ years expIQVIA is a leading global provider of clinical research services, and they are seeking a Regulatory Start Up Specialist to perform tasks associated with Site Activation activities. The role involves serving as a point of contact for investigative sites, ensuring adherence to regulations and SOPs, preparing regulatory documents, and monitoring project timelines.
AnalyticsHealth CareLife Science
Responsibilities
Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines
Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members
Prepare site regulatory documents, reviewing for completeness and accuracy
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information
Review and provide feedback to management on site performance metrics
Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed
Inform team members of completion of regulatory and contractual documents for individual sites
Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines
Provide local expertise to SAMs and project team during initial and on-going project timeline planning
Perform quality control of documents provided by sites
May have direct contact with sponsors on specific initiatives
Qualification
Required
1 year clinical research experience. Equivalent combination of education, training and experience
Benefits
Incentive plans
Bonuses
Health and welfare and/or other benefits
Company
IQVIA
IQVIA provides analytics, compliance, and management solutions to the life sciences industry.
10001+ employees
H1B Sponsorship
IQVIA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (294)
2023 (261)
2022 (229)
2021 (208)
2020 (180)
Funding
Current Stage
Public CompanyTotal Funding
$3.5B2025-06-02Post Ipo Debt· $2B
2023-11-14Post Ipo Debt· $500M
2023-05-18Post Ipo Debt· $1B
Leadership Team
Chris Colapietro
Vice President, Customer Engagement
Jonathan Morris
VP & GM US Healthcare
Recent News
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