Clinical Study Start-Up Specialist

Job Summary

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

Key Responsibilities:

• Act as the primary contact for investigative sites during site start-up activities, ensuring timely collection of required documents
• Coordinate and prepare submissions for EC/IRB/Third body/Regulatory Authorities, ensuring compliance with regulations
• Maintain awareness of regulatory standards and assist in the strategy definition for site activation

Required Qualifications:

• University/College degree in life sciences or related field, or equivalent certification with 2 years of clinical research experience
• High School Diploma with a minimum of 2 years of clinical research experience may be considered
• Strong working knowledge of ICH guidelines and RA, IRB/IEC regulations
• Minimum 2 years of experience in clinical development or start-up/regulatory processes
• Familiarity with investigator start-up documents and contract/budget negotiation processes