Clinical Start-Up Specialist

Job Summary

A company is looking for a Start Up Specialist, FSP.

Key Responsibilities:

• Maintain awareness of regulatory legislation and coordinate required documentation for submissions to EC/IRB/Third body/Regulatory Authorities
• Ensure compliance with applicable laws and guidelines while managing start-up and maintenance activities
• Serve as the primary contact for investigative sites, ensuring timely collection and quality review of necessary documents

Required Qualifications:

• University/College degree (life science preferred) or relevant certification with 2 years of clinical research experience
• High School Diploma or equivalent with a minimum of 2 years of clinical research experience may be considered
• Minimum of 2 years of experience in clinical development or start-up/regulatory processes
• Strong working knowledge of ICH guidelines and RA, IRB/IEC regulations
• Experience working with Canadian sites and strong negotiation skills with Canadian and US sites