Study Start-up Regulatory Assistant

About UsEach of CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, Endocrinology/Metabolic, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including HealthInsurance, Dental, Vision, LTD, STD, Life Ins, and 401k.Job SummaryThe Study Start-up Regulatory Assistant provides essential support to the Study Start-up Regulatory Coordinators in managing regulatory start-up activities across multiple clinical trials and CenExel sites. This role assists in ensuring compliance with applicable regulations, institutional policies, Standard Operating Procedures (SOPs), and study-specific protocols. The Assistant contributes to the efficient execution of start-up processes for studies that may be multi-site, nationwide, or moderately complex, involving various assessments and interventions.Essential Responsibilities And Duties Assist in coordinating regulatory submissions across multiple sites involved in multi-center clinical trials. Support the preparation and compilation of regulatory packages for submission to study sponsors. Help obtain required signatures from investigators and site staff for regulatory documentation. Assist with the completion and submission of Institutional Review Board (IRB) applications and related materials. Process and distribute IRB-approved documents and protocol amendments to participating sites. Ensure consistency in documentation and communication across sites under the direction of the Regulatory Coordinators. Track and support timely processing and distribution of regulatory packages and IRB approvals. Maintain and organize study start-up documents, including protocols and informed consent forms, in regulatory binders. Assist in preparing Delegation of Authority (DOA) logs and training logs for Site Initiation Visits (SIVs). Facilitate communication between IRBs, investigators, and sites as directed. Submit subject-facing documents for translation across studies and sites, as needed. Update and maintain regulatory information in Clinical Conductor or other designated systems. Support regulatory inspections and sponsor audits under the guidance of Regulatory Coordinators. Adhere to FDA regulations, ICH-GCP guidelines, CenExel SOPs, site-specific practices, and study protocols. Perform other duties as assigned to support regulatory start-up activities.Education/Experience/Skills High school diploma or GED required; coursework or certification in clinical research or regulatory affairs is preferred. 1–2 years of experience in clinical research or administrative support, preferably in a regulatory or compliance setting. Strong organizational and time management skills with attention to detail. Ability to manage multiple tasks and prioritize effectively in a fast-paced environment. Basic understanding of the clinical research process and regulatory documentation. Excellent interpersonal and communication skills to work collaboratively with internal teams and external partners. Ability to follow instructions from multiple team members and complete tasks independently. Proficiency in Microsoft Office applications, especially Excel and Word. Willingness to learn and become proficient in eRegulatory systems, IRB portals, and sponsor/vendor platforms. Critical thinking skills and a proactive approach to problem-solving. Strong written and verbal communication abilities.Working Conditions Remote work arrangement Essential physical requirements include sitting, typing, standing, and walking. Reporting to work, as scheduled, is essential. Ability to work overtime, weekends, and/or holidays as needed. Ability to travel as needed.CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.