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Clinical Study Start-Up Specialist

Company: VirtualVocations
Location: Elgin
Posted on: April 21, 2025

Job Description:

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

Keywords: VirtualVocations, Janesville , Clinical Study Start-Up Specialist, Healthcare , Elgin, Wisconsin

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