Start-up Specialist, Phase I

Overview

Support clinical study start-up and maintenance activities by coordinating investigative sites, regulatory submissions, essential documents, and site activation timelines.

What you'll do

• Coordinate and track documents for EC/IRB, regulatory authority, and third-body submissions.
• Prepare country application forms, cover letters, routine submissions, and informed consent forms.
• Serve as the primary contact for investigative sites during start-up and maintenance.
• Review, format, compile, and quality-check submission and site documents.
• Monitor timelines, budgets, deliverables, risks, and out-of-scope hours.
• Resolve and escalate study, submission, contract, budget, and consent issues.
• Mentor new hires and less-experienced colleagues when appropriate.

What you'll need

• At least 2 years of clinical research, clinical development, or start-up/regulatory experience.
• Strong working knowledge of ICH guidelines and RA and IRB/IEC regulations.
• Experience with investigator start-up documents.
• Understanding of research protocol requirements.
• University or college degree, preferably in life science, or related allied health certification.
• Ability to communicate protocol requirements and educate others.
• Ability to use in-house and off-the-shelf computer software.

Details

• Remote role for candidates residing in the United States.
• Frequent travel to client and site locations, with occasional domestic and international travel.
• Target pay range: $50,000–$70,000 yearly.
• Varied hours may be required.