Start-up Specialist, Phase I

Job Title: Start-up Specialist, Phase I Job Location: Remote United States Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Our CPS team is currently seeking a Study Start Up Specialist with 2+ years of start-up experience residing with the U.S.

Job Overview

Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site Readiness team and that documentation meets the specifications required by applicable regulations and sponsor.

Proactively interacts with EC/IRB/Third body/Regulatory Authorities to provide guidance regarding requirements. Maintain awareness of current regulatory standards related to submissions. Serve as local expert in project start-up activities for a particular country or region.

Act as a ‘knowledge resource’ to mentor and train new hires and less-experienced department colleagues if suitable. Summary of Responsibilities: Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries.

Coordinate, collect and organize data and information required by EC/IRB/Third body/Regulatory Authority including but not limited to the preparation of study documentation such as the country application form and cover letter for sponsor review as applicable.

Compile and prepare routine submission filed to IRB/IEC/Third body/Regulatory Authorities (e. g. , INDs/CTAs) and liaise with them as applicable regarding submission/approval. Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).

Perform a review of final submission documents as applicable. Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget and in