Start-Up Associate

h3Job Overview /h3 /brpPrimary 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. /p /brpPrimary 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. /p /brh3Summary Of Responsibilities /h3 /brul /brliDevelop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff. /li /brliAssist 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. /li /brliLiaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable). /li /brliPerform a review of final submission documents as applicable. /li /brliOrganize communication related to the submissions/outcomes within Fortrea as applicable. /li /brliEscalate study issues appropriately and in a timely fashion. /li /brliPerform other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable). /li /br /ul /brh3In Country specific tasks (Global) /h3 /brul /brliServe as primary contact for investigative sites and ensure documents required are collected in a timely manner. /li /brliCollect 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. /li /brliEnsure 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. /li /brliUpdate study documents when there are changes in study personnel/study amendments. /li /brliEnsure high quality documents are filed and systems are updated on an ongoing and timely basis, making Fortrea ready for an audit at any time. /li /brliUpdate status reports, applicable logs, and tracking systems as applicable for the projects with input provided by senior staff. /li /brliWith guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements. /li /brliMay support / assist the contract negotiation process under supervision of an experienced colleague or line manager. /li /brliProactively identifying and escalating to Submission Leads any risk to meeting deliverables. /li /brliNotify the Submissions Lead of hours identified as Out-of-Scope or over burn with the support of more senior specialists. /li /brliAll other duties as needed or assigned. /li /br /ul /brh3Clinical Trials Information System (CTIS) tasks (specific centralized role for EU) /h3 /brul /brliUpload of submission documentation to CTIS under supervision as applicable. /li /br /ul /brh3Qualifications (Minimum Required) /h3 /brul /brliUniversity/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology). /li /brliFortrea may consider relevant and equivalent experience in lieu of educational requirements. /li /br /ul /brh3Experience (Minimum Required) /h3 /brul /brliMinimum 0 – 2 + years of experience, or an equivalent combination of education and experience to successfully perform the

key responsibilities
of the job. /li /brliWorking knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines /li /brliDemonstrated basic understanding of the clinical trial process. /li /br /ul /brh3Physical Demands/Work Environment /h3 /brul /brliGeneral Office Environment. /li /br /ul /brpLearn more about our EEO Accommodations request here. /p