Regulatory Specialist

Avera•Sioux Falls, SD

1d•Onsite

About The Position

Works under general direction to perform professional-level clinical research regulatory assignments. Prepares and completes regulatory documents for protocols as requested by investigators, sub-investigators, and clinical research coordinators. Submits all required research documents to the protocol sponsor, the Institutional Review Boards (IRB), the FDA, and any other regulatory agency as required by the research project. This position works with researchers and partners in community-based settings and is responsive to the unique needs of community settings, such as tribal communities, schools, and non-profits, while aligning with standard regulatory expectations.

Requirements

The individual must be able to work the hours specified.
To perform this job successfully, an individual must be able to perform each essential job function satisfactorily including having visual acuity adequate to perform position duties and the ability to communicate effectively with others, hear, understand and distinguish speech and other sounds.
Bachelor's degree
2 years regulatory, quality or data analyst experience

Nice To Haves

1-3 years related research experience and/or training

Responsibilities

Prepares, 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.