Regulatory Specialist

Avera Health; Sioux Falls (SD); On-site; USD 43,000 - 66,000; Full time

Benefits offered by this job

PTO from day 1

401(k) employer match 5%

Career development

Job summary

Avera Health seeks a Regulatory Affairs Professional to prepare and submit regulatory documents for protocols, manage submissions to IRBs, the FDA, and sponsors, and maintain audit-ready regulatory systems. This role supports investigator-initiated and grant-funded research across community and tribal settings.

Ideal candidates have a Bachelor’s degree with 2 years related regulatory, quality, or data analysis experience, plus 1–3 years of related research exposure.

Qualifications

• Bachelor's degree required.
• 2 years regulatory, quality, or data analyst experience.
• 1-3 years related research experience preferred.

Responsibilities

• Prepares regulatory documents for protocols and submits to IRBs, FDA, and sponsors.
• Manages study start-up activities including regulatory submissions and site readiness.
• Maintains electronic regulatory systems and audit-ready binders and training records.
• Tracks training and delegated responsibilities to ensure compliance with GCP and policies.
• Contributes to grant applications by developing regulatory content and progress reports.
• Coordinates community engagement plans and aligns with tribal requirements.
• Collaborates with Tribal IRBs and community leaders to ensure ethical research practices.
• Trains staff on culturally aligned research practices.

Skills

Regulatory affairs

Quality assurance

Data analysis

Education

Bachelor's degree

Job description

Location:

Avera Research Institute-Sioux Falls

Worker Type:

Regular

Work Shift:

Day Shift (United States of America)

Pay Range:

$20.75 - $31.50

Position Highlights

You Belong at Avera

Be part of a multidisciplinary team built with compassion and the goal of Moving Health Forward for you and our patients. Work where you matter.

A Brief Overview

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.

What you will do

• 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.

Essential Qualifications

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. These requirements and those listed above are representative of the knowledge, skills, and abilities required to perform the essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions, as long as the accommodations do not cause undue hardship to the employer.

Required Education, License/Certification, or Work Experience:

• Bachelor’s
• 2 years regulatory, quality or data analyst

Preferred Education, License/Certification, or Work Experience:

• 1-3 years related research experience and/or training

Expectations and Standards

• Commitment 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 Some

Avera is proud to offer a wide range of benefits to qualifying part-time and full-time employees. We support you with opportunities to help live balanced, healthy lives. Benefits are designed to meet needs of today and into the future.

• PTO available day 1 for eligible hires.
• Up to 5% employer matching contribution for retirement
• Career development guided by hands-on training and mentorship

Avera 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 1-605-504-4444 or send an email to [e-mail].