Regulatory Specialist I
Core
Administrative and coordinative support for the design, implementation, and evaluation of clinical trials, ensuring regulatory compliance and managing study documentation.
Role type
Regulatory Specialist I (Clinical Trials)
Builds
FDA-regulated clinical trials and research studies
Domain
Healthcare / Oncology Research
Deliverable
client delivery
Required skills
Regulatory compliance management, study document preparation, budget negotiation, data entry, quality control monitoring, audit preparation
Preferred skills
Master's degree in relevant discipline, SOCRA or ACRP certification, budget/financial tracking experience
Technologies
OnCore (WISER), EPIC, Microsoft Products
Responsibilities
Ensure compliance with IRB SOPs and GCP guidelines; prepare and submit regulatory documents and consent forms; negotiate study budgets; maintain audit-ready study files; schedule site selection and initiation visits; track study activities and adverse events in databases; support study closure activities.
Seniority
Entry-level to Mid-level, individual contributor
