Clinical Trial Study Start-Up & Regulatory Specialist
Clinical Operations | San Diego, CA | Full Time
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 Director of Operations, the Regulatory & Data Entry Specialist will be responsible for various activities to include initial study submissions, regulatory updates, EDC entry, support with eRegulatory/eSource, and other QC-related tasks as assigned.
Company Name: Artemis Institute for Clinical Research
Title of Position: Clinical Research Regulatory & Data Entry Specialist
Position Type: Full Time
Pay Range: $20- $28/ hour Based on Experience
Location: San Diego-Hillcrest (hybrid remote may be an option)
Travel: 10%
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 the 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 closeout visits
- Enter EDC within protocol specified timelines
- Conduct periodic QC; including eSource, eRegulatory, Delegation Logs, Training Documentation, etc
- Other duties as assigned
Skills/Competencies:
- Able to effectively and diplomatically work with study Sponsors and the internal Artemis team
- Possess an 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:
- We always put patients first
- We deliver the best customer experience
- We do the right thing
- We work as a team
- We embrace a journey of continuous improvement