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Research Regulatory Coordinator

Location:
Boise, ID
Company:
St. Luke's Health System

Description

St. Luke’s Health System in Boise is seeking a Research Regulatory Coordinator to join our Research Operations team.

Position Summary
The RRC is responsible for ensuring timely submission of complete and accurate documents to study sponsors, the IRB and other regulatory authorities. The RRC will comply with Code of Federal Regulations, International Conference of Harmonization Guidelines, Office for Human Research Protection Standards and St. Luke’s Health System Policies and Procedures. The RRC participates in external and internal audits by preparing all regulatory records and documentation for auditor review and serves as a resource for investigators and staff in regulatory matters. Our ideal candidate is someone who can take big ideas and turn them into tactical steps that can be executed upon. The person needs to have strong interpersonal skills, be very detailed, and have excellent communication skills. Also, must be willing to have fun, work hard, and have a true passion to help solve problems and help others!


  • Prepares and submits regulatory documents for all submissions to St. Luke's Research and the IRB of record on behalf of investigators.
  • Maintains current regulatory documents in accordance with federal and state regulations, as well as institutional policies.
  • Develops appropriate regulatory reports and associated documentation in accordance with institutional policies, procedures, and study specific processes.
  • May prepare and maintain safety reports for submission to the IRB and/or sponsor.
  • Monitors various external websites to access protocol revisions, updates, safety reports etc.
  • Ensures Principal Investigator and research staff have access to current versions of all study documents and training materials.
  • May participate in creation, implementation, and documentation of study specific training.
  • Manages appropriate databases, websites, and clinical trial management systems.
  • Acts as a liaison with sponsors, research staff, and non-research personnel.
  • Prepares for and conducts study monitor visits and various audits.
  • May participate in development of regulatory policies and procedures.
  • Performs other duties and responsibilities as assigned.

  • Education: Bachelor’s Degree or 4 years relevant experience in lieu of degree.
  • Experience: 2 years of additional relevant experience.
  • Licenses/Certifications: None

A strong, talented staff is at the heart of St. Luke’s Health System. We are the state’s largest employer with more than 15,000 employees and a medical staff of more than 1,800 physicians and advanced practice providers. We’re proud of our people who deliver skilled, compassionate care every day, and are looking to add dedicated individuals who will continue this same tradition of excellence.

ABOUT BOISE

Known as the "City of Trees," Boise is Idaho's capital city—both a cultural center and a playground for those who love the outdoors. A vibrant downtown area affords fine dining, theatre, music, and college and semi-professional sports. Downtown Boise's main attractions include the Idaho State Capitol, the classic Egyptian Theatre, the Boise Art Museum, Julia Davis Park and Zoo Boise. The Greenbelt follows the beautiful Boise River corridor for more than 30 miles, and the Boise foothills are home to miles of hiking and biking trails.

Learn more about what the City of Trees has to offer you:

St. Luke’s Health System | Boise Convention and Visitors Bureau | Boise Parks and Recreation | Boise Museum Association | Boise Music Festival | Boise Philharmonic | Downtown Boise Restaurants | Boise Valley Economic Partnership | Hyde Park events | Treefort Music Festival | First Thursdays | Alive After Five | Capitol City Public Market | Runs and Triathlons | Shakespeare Festival | Sawtooth National Forest | Visit Idaho.org

*St. Luke’s is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other status or condition protected by law.

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