{"schemaVersion":"jobsearcher.job.v1","id":"fd671bdcea80873efe0ffdbf","url":"https://jobsearcher.com/jobs/fd671bdcea80873efe0ffdbf","canonicalUrl":"https://jobsearcher.com/jobs/fd671bdcea80873efe0ffdbf","title":"FSP Study Start-Up Associate","description":"Job Overview:\n\nPrimary contact with investigative sites during study maintenance and -when assigned-, site startup activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the timelines agreed with project management and Site Readiness team. Develop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff.\n\nSummary of Responsibilities:\n\nDevelop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff.\nAssist senior staff to compile, prepare, submit, and obtain approval of the submission documents to IRB/IEC/Third body/Regulatory Authority in accordance with local requirements.\nLiaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).\nPerform a review of final submission documents as applicable.\nOrganize communication related to the submissions/outcomes within Fortrea as applicable.\nEscalate study issues appropriately and in a timely fashion.\nPerform other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable).\nIn Country specific tasks (Global):\nServe as primary contact for investigative sites and ensure documents required are collected in a timely manner.\nCollect and track all the necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance.\nEnsure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines.\nUpdate study documents when there are changes in study personnel/study amendments.\nEnsure high quality documents are filed and systems are updated on an ongoing and timely basis, making Fortrea ready for an audit at any time.\nUpdate status reports, applicable logs, and tracking systems as applicable for the projects with input provided by senior staff.\nWith guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements.\nMay support / assist the contract negotiation process under supervision of an experienced colleague or line manager.\nProactively identifying and escalating to Submission Leads any risk to meeting deliverables.\nNotify the Submissions Lead of hours identified as Out-of-Scope or over burn with the support of more senior specialists.\nAll other duties as needed or assigned.\nClinical Trials Information System (CTIS) tasks (specific centralized role for EU):\nUpload of submission documentation to CTIS under supervision as applicable.\nManage and may lead the day-to-day operations within relevant support function to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives\nManage and may lead functional and cross-functional internal teams\nProvide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools\nProactively identify and escalate issues that arise related to support functional deliverables\nResponsible for implementation of standards for designated functional areas\nResponsible and may be accountable for all activities associated with relevant support function. This may include:\nManage Clinical Operations Compliance related activities inclusive of holistic evaluation of CO related audit findings, execution of CAPA and process related effectiveness checks, and CO inspection readiness support and/or\nManage Clinical Operations Vendor oversight/performance activities inclusive of vendor capability evaluation & selection, management of assigned vendors, planning/delivery of vendor governance meetings, analysis of key performance measures, vendor issue escalation etc. and/or\nManage and provide operational support of the global study operating model inclusive of development and maintenance/optimization of various CO business processes and service provider related operating models (CRO, IRT, Central Lab) and/or\nManage the sustainability and optimization of internal and external business process standards for Clinical Operations and/or\nManage and provide operational support related to systems and system/technology standards for the CO organization and/or\nManagement of CO QD changes and training related assignments/curriculum and staff onboarding activities\nProvide oversight and direction to team members for functional and study-related deliverables\nParticipate in process improvement and quality-related initiatives associated with study execution and deliverables\nSupport and implement Study Start Up activities including global site and country level feasibility, site start up and activation, regulatory and ethics document preparation and submission\nResponsible for the management of functional budgets and resources (where appropriate) and management of related components of trial or support function budgets, timelines and resources. May also provide oversight for these activities.\n\nQualifications (Minimum Required):\n\nBA/BS degree with 5 years of experience in pharmaceutical related drug development or direct equivalent experience or advanced degree\n\nExperience (Minimum Required):\n\nMinimum 0 – 2 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.\nWorking knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines\nDemonstrated basic understanding of the clinical trial process.\nMust have knowledge of clinical trial conduct, including, multi-center, global trials.\nMust have strong knowledge of ICH/GCP guidelines and regulatory requirements.\nRequires proven project management skills and leadership ability\nMust have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.\nFluent in English.\n\nPay Range: $27-30/hour\n\nBenefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable\n\nPhysical Demands/Work Environment:\n\nGeneral Office Environment.\nMinimal (10-15%) travel required\n\nLearn more about our EEO & Accommodations request here .","company":"Fortrea","rawCompany":"fortrea","city":"Durham","state":"NC","isRemote":false,"isActive":false,"createdAt":"2026-08-27T11:54:21.320Z","occupations":[{"code":"13-1041.07","title":"Regulatory Affairs Specialists","slug":"regulatory-affairs-specialists"},{"code":"11-9121.01","title":"Clinical Research Coordinators","slug":"clinical-research-coordinators"},{"code":"11-9199.01","title":"Regulatory Affairs Managers","slug":"regulatory-affairs-managers"}],"industries":[{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"541611","title":"Administrative Management and General Management Consulting Services","slug":"administrative-management-and-general-management-consulting-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"FSP Study Start-Up Associate","description":"Job Overview:\n\nPrimary contact with investigative sites during study maintenance and -when assigned-, site startup activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the timelines agreed with project management and Site Readiness team. Develop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff.\n\nSummary of Responsibilities:\n\nDevelop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff.\nAssist senior staff to compile, prepare, submit, and obtain approval of the submission documents to IRB/IEC/Third body/Regulatory Authority in accordance with local requirements.\nLiaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).\nPerform a review of final submission documents as applicable.\nOrganize communication related to the submissions/outcomes within Fortrea as applicable.\nEscalate study issues appropriately and in a timely fashion.\nPerform other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable).\nIn Country specific tasks (Global):\nServe as primary contact for investigative sites and ensure documents required are collected in a timely manner.\nCollect and track all the necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance.\nEnsure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines.\nUpdate study documents when there are changes in study personnel/study amendments.\nEnsure high quality documents are filed and systems are updated on an ongoing and timely basis, making Fortrea ready for an audit at any time.\nUpdate status reports, applicable logs, and tracking systems as applicable for the projects with input provided by senior staff.\nWith guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements.\nMay support / assist the contract negotiation process under supervision of an experienced colleague or line manager.\nProactively identifying and escalating to Submission Leads any risk to meeting deliverables.\nNotify the Submissions Lead of hours identified as Out-of-Scope or over burn with the support of more senior specialists.\nAll other duties as needed or assigned.\nClinical Trials Information System (CTIS) tasks (specific centralized role for EU):\nUpload of submission documentation to CTIS under supervision as applicable.\nManage and may lead the day-to-day operations within relevant support function to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives\nManage and may lead functional and cross-functional internal teams\nProvide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools\nProactively identify and escalate issues that arise related to support functional deliverables\nResponsible for implementation of standards for designated functional areas\nResponsible and may be accountable for all activities associated with relevant support function. This may include:\nManage Clinical Operations Compliance related activities inclusive of holistic evaluation of CO related audit findings, execution of CAPA and process related effectiveness checks, and CO inspection readiness support and/or\nManage Clinical Operations Vendor oversight/performance activities inclusive of vendor capability evaluation & selection, management of assigned vendors, planning/delivery of vendor governance meetings, analysis of key performance measures, vendor issue escalation etc. and/or\nManage and provide operational support of the global study operating model inclusive of development and maintenance/optimization of various CO business processes and service provider related operating models (CRO, IRT, Central Lab) and/or\nManage the sustainability and optimization of internal and external business process standards for Clinical Operations and/or\nManage and provide operational support related to systems and system/technology standards for the CO organization and/or\nManagement of CO QD changes and training related assignments/curriculum and staff onboarding activities\nProvide oversight and direction to team members for functional and study-related deliverables\nParticipate in process improvement and quality-related initiatives associated with study execution and deliverables\nSupport and implement Study Start Up activities including global site and country level feasibility, site start up and activation, regulatory and ethics document preparation and submission\nResponsible for the management of functional budgets and resources (where appropriate) and management of related components of trial or support function budgets, timelines and resources. May also provide oversight for these activities.\n\nQualifications (Minimum Required):\n\nBA/BS degree with 5 years of experience in pharmaceutical related drug development or direct equivalent experience or advanced degree\n\nExperience (Minimum Required):\n\nMinimum 0 – 2 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.\nWorking knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines\nDemonstrated basic understanding of the clinical trial process.\nMust have knowledge of clinical trial conduct, including, multi-center, global trials.\nMust have strong knowledge of ICH/GCP guidelines and regulatory requirements.\nRequires proven project management skills and leadership ability\nMust have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.\nFluent in English.\n\nPay Range: $27-30/hour\n\nBenefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable\n\nPhysical Demands/Work Environment:\n\nGeneral Office Environment.\nMinimal (10-15%) travel required\n\nLearn more about our EEO & Accommodations request here .","datePosted":"2026-08-27T11:54:21.320Z","dateModified":"2026-08-27T11:54:21.320Z","hiringOrganization":{"@type":"Organization","name":"Fortrea","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Durham","addressRegion":"NC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"fd671bdcea80873efe0ffdbf"},"url":"https://jobsearcher.com/jobs/fd671bdcea80873efe0ffdbf"}}