Regulatory Analyst II

This position is responsible for the regulatory lifecycle management of oncology clinical trials. The specialist serves as the primary liaison between Principal Investigators, institutional review boards (IRBs), federal agencies (FDA), and industry sponsors to ensure all research activities comply with state and federal regulations, as well as institutional standard operating procedures (SOPs).

• Independently manages the preparation and submission of research plans, protocols, and regulatory documents to the IRB.
• Drafts and edits Informed Consent Documents (ICDs), translating complex medical procedures and risks into layperson-friendly language.
• Oversees protocol amendments, annual renewals, and the reporting of unexpected problems or protocol deviations.
• Serves as a subject matter expert for Adverse Event (AE) and Serious Adverse Event (SAE) reporting to ensure human subject protection.
• Maintains "gold standard" regulatory binders (electronic and paper) and develops audit checklists to mitigate institutional risk.
• Manages Investigator CVs, FDA 1572 forms, and clinical lab certifications.
• Ensures all administrative records adhere to university and federal retention and destruction policies.
• Works with senior staff to prepare and file Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications or exemptions.
• Manages the registration and data entry of clinical trials into the Clinical Trials.gov database to meet federal requirements.
• Synthesizes Investigator Brochures to create Investigational Drug Fact Sheets for clinical staff.
• Coordinates with ancillary committees (Biosafety, Stem Cell, Data Safety Monitoring) to align submission timelines with committee meeting dates.
• Maintains large-scale tracking databases and Clinical Trial Management Systems (CTMS) to provide real-time status reports on the research portfolio.
• Identifies bottlenecks in the submission pipeline and proposes solutions to enhance workflow.

• Bachelor’s degree in a science/social science field or equivalent experience.
• Proven track record in a clinical research environment (Academic, CRO, or Research Hospital).
• Deep experience with
  
  FDA policies, GCP, and NIH guidelines.

• Strong knowledge of protocol design, data management, and query resolution.
• Familiarity with
  
  IRB administration, Bloodborne Pathogens, and IATA shipping standards.
• Proficiency in MS Office and Clinical Trial Management Systems (CTMS) like Velos.
• High-level English fluency (written/verbal) with the ability to translate medical jargon

• Oncology specific research experience.
• Professional Certification (SoCRA, ACRP, or RAPS).
• Experience with Investigator-initiated or National Group trials.
• Bilingual skills (Spanish, Korean, Vietnamese, or Chinese).