Job Description

$25-$26/hour for entry-level candidates, with potential flexibility for directly relevant experience Strong benefits package, including health, dental, vision, 401(k) match, PTO, paid holidays, and tuition reimbursement Opportunity to join a fast-growing clinical research site network with 34 sites across 10 states and continued growth expected in 2026 and beyond COMPANY Our client is a rapidly growing clinical research site network with ~30 locations across 10 states. The organization continues to expand, creating strong career growth potential in an entrepreneurial, fast-moving environment. This is a great opportunity for someone who is detail-oriented, organized, and interested in building a career in clinical research operations or regulatory affairs. POSITION The Regulatory Specialist will support the regulatory side of clinical research studies by preparing, maintaining, and tracking important study documents. This person will work closely with site leadership, investigators, sponsors, IRBs, and internal teams to help ensure studies are properly documented and compliant. This role can be a strong fit for candidates with clinical research experience, healthcare administration experience, medical office experience, or experience in another highly regulated environment. Direct clinical research experience is preferred, but not required for candidates with strong organization, communication, and attention to detail. RESPONSIBILITIES Prepare, maintain, and organize regulatory documents for active clinical research studies Support regulatory submissions to IRBs, sponsors, and other regulatory parties Track study updates, amendments, consent forms, FDA 1572s, safety information, and other key documents Maintain accurate paper and electronic regulatory files, logs, and document archives Help prepare for monitoring visits, audits, and sponsor review activities Communicate professionally with internal teams, sponsors, IRBs, and other external partners QUALIFICATIONS High school diploma or equivalent required; college degree preferred 0-3+ years of experience in clinical research, healthcare administration, medical office administration, or another regulated environment Strong attention to detail, organization, follow-through, and written communication skills Comfortable using Microsoft Office, Office365, and electronic document systems; CTMS or eReg/eDocs experience is a plus Able to work both independently and collaboratively in a fast-paced environment Professional, ethical, and able to maintain confidentiality when working with study documents and protected health information #J-18808-Ljbffr SQRL

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