Regulatory Specialist

Clinical Research Regulatory CoordinatorLocation: Avera Research Institute-Sioux FallsWorker Type: RegularWork Shift: Day Shift (United States of America)Pay Range: $20.75 - $31.50Position HighlightsBe part of a multidisciplinary team built with compassion and the goal of Moving Health Forward for you and our patients. Work where you matter.What You Will DoPrepares, submits, and maintains regulatory documents (including informed consent, correspondence, safety reports, and continuing reviews) to sponsors, CROs, and Institutional Review Boards (IRBs) in compliance with applicable regulations and contracts.Manages study start-up activities, including regulatory submissions, feasibility assessments, and site readiness for clinical and community-based research locations.Maintains electronic regulatory systems and ensure all regulatory binders, delegation logs, and training documentation are complete, accurate, and audit-ready.Tracks and documents study-specific training and delegated responsibilities to ensure compliance with GCP, institutional policies, and protocol requirements.Supports investigator-initiated and physician initiated research by developing study protocols and converting funded grant applications into compliant research protocols.Conducts literature reviews and assist in the preparation of regulatory content for grant applications, progress reports, and sponsor updates.Coordinates regulatory components of community engagement plans and ensure research activities align with institutional, community and tribal requirements.Collaborates with community leaders, advisory boards, and Tribal IRBs to ensure culturally appropriate and ethically conducted research.Participates in and coordinate research-specific meetings to support regulatory compliance, study progress, and effective communication among investigators, sponsors, and community partners.Trains research staff on culturally aligned research practices.Essential QualificationsBachelor's2 years regulatory, quality or data analystExpectations and StandardsCommitment to the daily application of Avera's mission, vision, core values, and social principles to serve patients, their families, and our community.Promote Avera's values of compassion, hospitality, and stewardship.Uphold Avera's standards of Communication, Attitude, Responsiveness, and Engagement (CARE) with enthusiasm and sincerity.Maintain confidentiality.Work effectively in a team environment, coordinating work flow with other team members and ensuring a productive and efficient environment.Comply with safety principles, laws, regulations, and standards associated with, but not limited to, CMS, The Joint Commission, DHHS, and OSHA if applicable.Benefits You Need & Then SomePTO available day 1 for eligible hires.Up to 5% employer matching contribution for retirementCareer development guided by hands-on training and mentorshipAvera is an Equal Opportunity Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, Veteran Status, or other categories protected by law. If you are an individual with a disability and would like to request an accommodation for help with your online application, please call View phone number on click.appcast.io or send an email to View email address on click.appcast.io.