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Regulatory Assistant

Clinical Operations | San Diego, CA | Full Time

Job Description

Want to be a part of a growing company that’s making a difference in our world?  Look no further than Artemis Institute for Clinical Research!  You’ll enjoy a friendly and exciting culture with opportunities for growth and advancement.  

Artemis Research is a leading Principal Investigator and Patient Focused clinical research company dedicated to advancing medical treatments. Established in 2008 by colleagues who bring more than 50 years of combined research experience, Artemis specializes in Psychiatry/Neurology and Internal Medicine. With multiple locations serving Southern California, each Artemis site is fully equipped to conduct complex clinical research trials. 

Position Overview:

Under the supervision of the Quality and Regulatory Manager, the Regulatory Assistant will be responsible for various activities to include initial study submissions, regulatory updates, support with eRegulatory/eSource and other QC related tasks as assigned. 

Company Name: Artemis Institute for Clinical Research

Title of Position:  Regulatory Assistant

Position Type: Full Time

Pay Range:  Based on Experience

Location: San Diego-Hillcrest

Travel: <10% (traveling to our Riverside site is an opportunity)

Work Schedule:  Monday & Thursday 8:30 AM – 5:00 PM and Tuesday, Wednesday, Friday 7:00 AM – 3:30 PM

Required Education and Experience:

  • Experience in the field of quality and/or clinical research is a plus!

Description of Responsibilities: 

  • Assist with the preparation of initial study documents, ensuring full submission within 5 days of receipt 
  • Assist with creation and ongoing maintenance of CVs, certifications and licensures
  • Monitor IRB portals for updates and ensure site staff are made aware immediately 
  • eFile Regulatory documents 
  • Assist with regulatory related tasks at monitoring and close out visits
  • Create and implement eSource changes based on site staff feedback
  • Conduct periodic QC; including eSource, eRegulatory, Delegation Logs, Training Documentation, etc
  • Other duties as assigned by QC and Regulatory Manager
     

Skills/Competencies:  

  • Able to effectively and diplomatically work with study Sponsors and the internal Artemis team
  • Possess and eye for quality and care for details
  • A self-starter who takes initiative
  • A team player who can receive and provide constructive feedback
  • Excellent professional communication, punctual, and responsible
  • Hard working with the ability to “roll up the sleeves”
  • Willingness to learn new tasks and grow with the company

How to Apply:  Click Here to apply and select “Apply for this job” in the top right corner.

Company Core Values:

  1. We always put patients first
  2. We deliver the best customer experience
  3. We do the right thing
  4. We work as a team
  5. We embrace a journey of continuous improvement