Hiring: Regulatory Associate Company: K2 Medical Research Location: Ocala, FL Job Posted Time: 2026-09-10 10:39:51 Employment Type: Full-time Target Skills & Keywords : GCP, Microsoft Excel, Project Management, Regulatory Compliance About the job Required Skills: •IRB Oversight & Submissions: Prepare, submit, and track initial study submissions, protocol amendments, continuing reviews, safety reports, and informed consent forms (ICFs) to central and local Institutional Review Boards (IRBs). •Delegation of Authority (DOA) Logs: Maintain and audit Delegation of Authority (DOA) logs, ensuring all site staff signatures, training records, and regulatory binder documents are accurate and fully compliant prior to study participation. •Study Start-Up & Timeline Management: Drive study start-up workflows from initial packet receipt through site initiation visits (SIV) and study activation. Proactively manage trial trackers and study timelines to prevent bottlenecks. •Regulatory Compliance & Audits: Maintain essential electronic regulatory documents (eReg) in compliance with Good Clinical Practice (GCP), FDA regulations, and Sponsor guidelines. Serve as the primary regulatory point of contact for Sponsor/CRO monitors and auditors. •High-Volume Multitasking & Tracking: Manage high-volume, concurrent clinical trials across varying stages of study lifecycle. Drive rigorous follow-up with internal teams, Sponsors, and IRBs to ensure actionable items are closed efficiently. Qualifications: •Strong technical proficiency in eReg systems, clinical trial software, and advanced study-tracking tools (Excel/eTMF). •In-depth, operational understanding of IRB submission processes, regulatory workflows, and DOA log maintenance. •Exceptional organization, multi-tasking, and timeline-management capabilities in a high-volume environment. •Strong follow-up skills with high accountability and attention to detail. •Actively facilitate and support organization's goals, missions, and values . •Demonstrated capacity to work collaboratively across departments to ensure seamless operational flow . •Site-Level Regulatory Experience: Must have site-level regulatory exposure in clinical trials. Experience in Study Start-Up processes is strongly preferred. •Diverse Backgrounds Encouraged: Candidates with strong Clinical Research Coordinator (CRC) or Project Manager (PM) backgrounds who possess significant regulatory exposure are encouraged to apply. •Sponsor / CRO / CRA Backgrounds: Transferable candidates from Sponsor, CRO, or CRA roles seeking site-level operational roles are welcome to apply (salary alignable with site-level structures). •Join the K2 Family: Where Compassion and Connection Lead the Way! At K2 Medical Research, people come first and we're seeking warm, wonderful humans who effortlessly click with everyone, from our incredible patients to brilliant physicians and dedicated research staff. Compensation: •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!