Find & Apply For Clinical Research Coordinator Jobs in Daytona Beach, Florida

Overview Position Summary The Regulatory Associate supports the regulatory and administrative activities necessary for the initiation, conduct, maintenance, and closeout of clinical research studies. This position works closely with investigators, study coordinators, sponsors, CROs, IRBs, and internal staff to ensure regulatory documentation is complete, accurate, organized, and maintained in accordance with study requirements, Good Clinical Practice (GCP), and applicable regulations. Essential Duties and Responsibilities Prepare, collect, review, and maintain regulatory documents for clinical research studies. Assist with initial study submissions, amendments, continuing reviews, safety reports, and study closeouts to Institutional Review Boards (IRBs). Maintain regulatory binders and electronic regulatory files throughout the life of each study. Collect and maintain investigator and staff documents, including CVs, licenses, certifications, training records, financial disclosures, and delegation-related documentation. Assist with FDA Form 1572 preparation and maintenance, when applicable. Track regulatory document expiration dates and obtain updated documents in a timely manner. Assist with study start-up activities and collection of essential documents required for site activation. Review regulatory files for completeness and identify missing, expired, or inconsistent documentation. Maintain current protocol versions, informed consent forms, investigator brochures, manuals, and other study documents. Distribute and document protocol amendments and other regulatory updates to appropriate study personnel. Support preparation for sponsor monitoring visits, audits, and regulatory inspections. Respond promptly and accurately to regulatory document requests from sponsors and CROs. Assist with maintaining staff training documentation and study-specific training records. Communicate with study teams regarding regulatory deadlines and outstanding documentation. Maintain confidentiality of participant, study, and business information. Perform other regulatory and clinical research administrative duties as assigned. Qualifications Associate or bachelor's degree preferred, particularly in healthcare, life sciences, business, or a related field. Clinical research, regulatory, healthcare, or medical office experience preferred. Familiarity with FDA regulations, ICH-GCP, IRB requirements, and clinical research terminology preferred. Strong organizational skills and exceptional attention to detail. Ability to manage multiple studies, deadlines, and priorities simultaneously. Strong written and verbal communication skills. Proficiency with Microsoft Office and electronic document management systems. Ability to work independently while collaborating effectively with investigators and study teams. Key Competencies This position requires the ability to work efficiently and with a strong sense of urgency while maintaining a high degree of accuracy and attention to detail. Timeliness is important, but should never come at the expense of quality or regulatory compliance. The successful candidate must also demonstrate patience, composure, and resilience in a fast-paced environment, including the ability to manage changing priorities, repetitive follow-up, tight deadlines, and occasional obstacles without becoming easily frustrated. Additional competencies include strong organization, accountability, follow-through, problem-solving, professional communication, adaptability, and the ability to proactively identify and resolve regulatory documentation issues. Working Environment This is primarily an office-based position within a clinical research site and requires frequent computer use, document review, communication with study partners, and coordination across multiple clinical trials.

Pay:

$40,000.00 - $45,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person