Clinical Study Start-Up Specialist

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

Apr 2, 2025 - 22:12

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