Research Regulatory Specialist

Job Summary As our Research Regulatory Specialist, you will play a pivotal role in advancing cutting‑edge clinical studies. We are seeking a meticulous and detail-oriented professional with a passion for clinical research and regulatory compliance. Responsibilities Every day you will coordinate and participate in clinical research studies, ensuring seamless operations from start to finish. You'll be responsible for the meticulous collection, documentation, and reporting of vital clinical research data, contributing directly to program management and grant funding success. To be successful in this role, you will handle study coordination, schedule subject visits, ensure adequate supplies, procedures, and investigator availability, provide individualized education to study subjects and their families, obtain necessary consents, collect and process protocol-required specimens, and act as a liaison between the Sponsor, Investigator, and Study Subject. Data Management & Reporting: collect all required study data and complete CRFs in a timely and accurate manner; prepare comprehensive project reports related to program management and grant funding. Regulatory Compliance & Quality Assurance: ensure study documents are maintained in strict compliance with applicable regulations, guidelines, and policies (e.g., FDA, OHRP, IRB); collaborate closely with investigators to identify adverse events and serious adverse events, ensuring subject safety and accurate, timely reporting; demonstrate exceptional customer service through professional interactions with Sponsors, study monitors, and internal departments; comply with all regulatory and policy requirements; maintain and apply deep knowledge of federal and state regulations governing the conduct of clinical trials. Requirements Required Associate’s degree in a related field OR an equivalent combination of relevant education and job-related experience in lieu of a degree Minimum of two (2) years of related experience in clinical research or regulatory affairs Competency in computer skills, including strong proficiency with Microsoft Office products (Word, Excel, Outlook, PowerPoint) Proven ability to coordinate and manage multiple tasks with high attention to detail Strong understanding of clinical trial processes and regulatory requirements (FDA, OHRP, IRB) Excellent written and verbal communication skills, including the ability to educate subjects and families effectively Proficiency in data collection and reporting Exceptional organizational and time management abilities Ability to work independently and as part of a collaborative team Preferred Bachelor’s degree in a related field Three (3)+ years of clinical experience Pay Range $24.33 - $36.19 /hour We are an equal opportunity/affirmative action employer. #J-18808-Ljbffr Dignity Health