Clinical Research Regulatory Specialist

Sioux Center Health; Sioux Falls (SD); On-site; USD 29,000 - 44,000; Full time

Benefits offered by this job

PTO from day 1

5% retirement match

Career development

Job summary

Avera Research Institute in Sioux Falls seeks a regulatory professional to handle clinical research regulatory assignments, preparing and submitting documents to IRBs, FDA, and sponsors. This role works with investigators and coordinators across community and tribal settings, ensuring regulatory compliance.

The ideal candidate has a Bachelor's degree and at least two years of regulatory or data analysis experience, with strong communication and attention to detail.

Qualifications

• Bachelor's degree required and 2 years regulatory, quality or data analyst experience.
• Ability to communicate effectively and maintain attention to detail.
• Visual acuity adequate to perform duties and support regulatory tasks.

Responsibilities

• Prepares, submits, and maintains regulatory documents to sponsors and IRBs in compliance with regulations.
• Manages study start-up activities including regulatory submissions and site readiness.
• Keeps electronic regulatory systems up-to-date and audit-ready documentation.
• Tracks training and delegated responsibilities to ensure protocol compliance.
• Supports investigator-initiated research by developing study protocols and grant content.
• Coordinates regulatory components of community engagement plans.

Skills

Regulatory knowledge

Data analysis

Effective communication

Education

Bachelor's degree

Job description

Avera Research Institute in Sioux Falls seeks a regulatory professional to handle clinical research regulatory assignments, preparing and submitting documents to IRBs, FDA, and sponsors. This role works with investigators and coordinators across community and tribal settings, ensuring regulatory compliance.

The ideal candidate has a Bachelor's degree and at least two years of regulatory or data analysis experience, with strong communication and attention to detail.