Clinical Research Start-Up Specialist

Job Summary

A company is looking for a Start Up Specialist to manage site start-up activities and ensure compliance with regulatory requirements.

Key Responsibilities:

• Maintain awareness of regulatory legislation and practices in assigned countries
• Coordinate and prepare necessary documentation for regulatory submissions and approvals
• Serve as the primary contact for investigative sites, ensuring timely collection and quality review of required documents

Required Qualifications:

• University/College degree (life science preferred) or certification in a related health profession, plus 2 years of clinical research experience
• Consideration of equivalent experience in lieu of educational requirements
• High School Diploma or equivalent with a minimum of 2 years' clinical research experience may also be considered
• Minimum of 2 years of experience in clinical development or start-up/regulatory processes
• Working knowledge of ICH, RA, IRB/IEC regulations, and familiarity with investigator start-up documents