# Study Start Up Specialist **Company**: Fortrea **Work arrangement**: remote **Experience**: senior **Job type**: full-time **Salary**: $50-70k **Category**: Healthcare **Industry**: Healthcare **Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Durham/Start-Up-Specialist---FSP_266245?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_31618acf-5f3 ## Description We are seeking a Study Start Up Specialist with 2+ years of start-up experience residing in the U.S. As a Study Start Up Specialist, you will serve as the primary contact with investigative sites during site start-up activities and maintenance. Your responsibilities will include collecting required investigator and essential documents for a study, ensuring EC/IRB/Third body/Regulatory Authority and other local applications are made within agreed timelines, and that documentation meets applicable regulations and sponsor specifications. **Responsibilities:** - Maintain awareness of regulatory legislation, guidance, and practice in assigned countries - Coordinate, collect, and organize data and information required by EC/IRB/Third body/Regulatory Authority - Compile and prepare routine submissions filed to IRB/IEC/Third body/Regulatory Authorities - Liaise with internal and external vendors in generating Regulatory Authority submissions - Perform a review of final submission documents - Ensure all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget, and in compliance with applicable laws and guidelines - Prevent and escalate study issues appropriately and in a timely fashion - Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner - Collect and track all necessary documents required and perform a quality review, formatting, and compilation of final documents for effective and compliant site activation and maintenance - Ensure high-quality documents are filed and systems are updated on an ongoing and timely basis - Participate in team and project meetings as applicable - Assist in strategy definition for Site Activation and provide accurate projections and timelines to study teams - Review and customize country and site-specific patient informed consent forms for compliance with local requirements and protocol - Support the negotiation of site contracts and budgets with sites, if applicable - Proactively identify and escalate risks to meeting deliverables **Qualifications:** - University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution - 2 years' work experience in clinical research, including a strong working knowledge of ICH guidelines and RA, IRB/IEC regulations - Relevant and equivalent experience in lieu of educational requirements may be considered **Experience:** - Minimum of 2 years of experience in clinical development or start-up/regulatory process - Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines - Familiarity with investigator start-up documents and contract/budget negotiation process - Previous interaction with operational project teams and investigative sites **Work Environment:** - Work is performed in an office environment with exposure to electrical office equipment - Frequent travel to clients/site locations with occasional travel both domestic and international **Physical Requirements:** - Ability to sit for extended periods and operate a vehicle safely - Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists - Occasional crouching, stooping, with frequent bending and twisting of upper body and neck - Ability to access and use a variety of computer software developed both in-house and off-the-shelf - Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs - Regular and consistent attendance - Varied hours may be required **Target Pay Range:** $50-70k ## Skills ### Required - ICH guidelines - RA - IRB/IEC regulations - clinical research - regulatory submissions --- Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Durham/Start-Up-Specialist---FSP_266245?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)