Regulatory Specialist

Job DetailsDALLAS, TX Fully Remote Full TimeDescriptionDescription:We are seeking an experienced, organized, and detail-oriented Regulatory Specialist with a strong background in clinical research and regulatory affairs. This role is integral to developing and maintaining regulatory documents, ensuring adherence to quality standards, and supporting the Clinical Operations department in regulatory processes. This role is responsible for the successful maintenance of regulatory documents, regulatory binders, and CTMS of all clinical trials.ResponsibilitiesMaintain compliance with local, state, GCP, ICH, and FDA regulations in clinical trial regulatory operations.Oversee regulatory processes at the clinical site in collaboration with study teams, investigators, CROs, and sponsors.Ensure timely completion of initial regulatory essential documents, IRB submissions, and approvals.Facilitate the completion of all organization- and study-specific training by relevant study staff.Participate in and lead the Regulatory component of kick-off meetings for new clinical studies to ensure all regulatory documents are completed and Regulatory team is prepared for study start.Ensure ongoing Regulatory study binder maintenance with completion of updated documents as required, processing of all study amendments, annual/continuing reviews, and ongoing required document filing through study close out.Responsible for ensuring ongoing study specific training is completed timely by Investigators/clinical staff and ongoing maintenance of Investigator/staff credentials.Assist QA-Regulatory Manager with review and revision of site SOPs on an as-needed basis. Particular focus will be paid to collaboration on updates to Regulatory SOPs and Work Processes to ensure ongoing compliance with all applicable regulations and industry best practices.Provide responsive and diligent collaboration with sponsor/CRO study teams, including prompt resolution of Regulatory pending action items.Conduct routine quality checks of regulatory binders and other regulatory documents in the company drive and CTMS.Foster effective and professional engagement with staff, providers and external clients.QualificationsQualifications:Bachelor’s degree, or a strong track record of relevant experience.2+ years of experience in clinical research regulatory affairs. Research site level experience preferred.Strong understanding of FDA regulations, ICH-GCP guidelines, IRB processes, Essential Document completion and maintenance/requirements.Ability to review clinical trial protocols for necessary information for study start-up and effectively support study start-up activities.Regulatory experience with Central IRB(s).Knowledge of research and regulatory terminology, clinical trials and GCP concepts.Detail oriented and meticulous in all aspects of work.Strong follow through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative.Must have professional demeanor, ability to communicate effectively with company clients (Sponsors, CROs) as well as Investigators and clinic teams, other departments that Regulatory may interact with frequently.Ability to work independently as well as in a team environment.Must be proficient in databases used in research environment or have a willingness to learn and demonstrate proficiency.Must be highly organized, with effective time management skills, ability to multitask/manage multiple projects effectively, and manage deadlines.