Fsp Regulatory & Start-up Specialist

IQVIA

Durham, North Carolina, United States
Base: $46,200.00 - $118,600.00 annualized; bonus/e...
Site activation activities
Regulatory document preparation
Clinical research experience
Perform tasks at a country level associated with Site Activation activities in accordance with applicable local and/or international regulations, standard operating procedures, project requirements and contractual/budgetary guidelines

Job Summary

  • Perform tasks at a country level associated with Site Activation activities in accordance with applicable local and/or international regulations, standard operating procedures, project requirements and contractual/budgetary guidelines.
  • Serve as Single Point of Contact in assigned studies for investigative sites, Site Activation Manager, Project Management team, and other departments as necessary.
  • IQVIA is proud to be an equal opportunity employer and is committed to integrity in the hiring process with a zero tolerance policy for candidate fraud.

Matching Summary

Perform tasks at a country level associated with Site Activation activities in accordance with applicable local and/or international regulations, standard operating procedures, project requirements and contractual/budgetary guidelines.

Salary

Base: $46,200.00 - $118,600.00 annualized; Bonus/Equity: Incentive plans and bonuses may be offered; Benefits: Range of health and welfare and/or other benefits

Skills & Requirements

Must-have

  • Site Activation activities
  • Regulatory document preparation
  • Clinical research experience
  • Project timeline management
  • Quality control of documents
  • Single Point of Contact (SPOC)

Nice-to-have

  • Local regulatory expertise
  • Collaboration with project teams
  • Sponsor communication
  • Contingency planning

Key Requirements

  • 2+ years clinical research experience
  • Bachelor's degree
  • Knowledge of SOPs and regulations

Work Rights

Not specified

Tailored Resume

Cover Letter