FSP Regulatory & Start Up Specialist 2
IQVIA · Durham, NC
RegulatoryFull-time$60k–$157kCompany career page
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Role summary
IQVIA seeks a regulatory and site activation specialist to manage country-level clinical trial activities, including site preparation, document coordination, and regulatory compliance. The role involves serving as a key contact between investigative sites, project teams, and internal departments to ensure adherence to procedures and timelines.
What they're looking for
- Bachelor's degree in life sciences or related field plus 3 years clinical research experience
- 3 years clinical research experience with 1 year in a leadership capacity
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Knowledge of GCP/ICH guidelines and applicable regulatory requirements
- Understanding of regulated clinical trial environment and drug development process
- Strong negotiation, communication, and interpersonal skills
- Ability to manage multiple projects independently and prioritize effectively
What you'll be doing
- Serve as single point of contact for assigned studies between sites, project management, and internal teams
- Prepare, review, and distribute site regulatory documents ensuring completeness and accuracy
- Track and coordinate progress of regulatory approvals, ethics documents, ICF, and investigator pack releases
- Maintain internal systems and databases with project-specific information and monitor site performance metrics
- Establish project timelines, implement monitoring measures, and execute contingency plans as needed
Privacy & handoff
This role links to IQVIA's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.