Study Start-Up Specialist

Job Summary

A company is looking for a Start-up Specialist.

Key Responsibilities:

• Act as the primary contact for investigative sites, ensuring timely collection and quality review of necessary documents
• Coordinate and prepare submissions to regulatory authorities while maintaining compliance with applicable regulations
• Monitor project timelines and deliverables, proactively identifying and escalating any risks to meeting deadlines

Required Qualifications:

• University/College degree in life sciences or certification in a related allied health profession, or equivalent experience
• Minimum of 2 years' experience in clinical research with knowledge of ICH guidelines and regulatory requirements
• Familiarity with investigator start-up documents and the contract/budget negotiation process
• Understanding of research protocol requirements and ability to communicate them effectively
• Experience in clinical development or start-up/regulatory processes