Start-Up Associate

h3Job Overview: /h3 pPrimary 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 h3Summary of

Responsibilities:
/h3 ul liDevelop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff. /li liAssist 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 liLiaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable). /li liPerform a review of final submission documents as applicable. /li liOrganize communication related to the submissions/outcomes within Fortrea as applicable. /li liEscalate study issues appropriately and in a timely fashion. /li liPerform other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable). /li /ul h3In Country specific tasks (Global): /h3 ul liServe as primary contact for investigative sites and ensure documents required are collected in a timely manner. /li liCollect 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 liEnsure 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 liUpdate study documents when there are changes in study personnel/study amendments. /li liEnsure 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 liUpdate status reports, applicable logs, and tracking systems as applicable for the projects with input provided by senior staff. /li liWith guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements. /li liMay support / assist the contract negotiation process under supervision of an experienced colleague or line manager. /li liProactively identifying and escalating to Submission Leads any risk to meeting deliverables. /li liNotify the Submissions Lead of hours identified as Out-of-Scope or over burn with the support of more senior specialists. /li liAll other duties as needed or assigned. /li /ul h3Clinical Trials Information System (CTIS) tasks (specific centralized role for EU): /h3 ul liUpload of submission documentation to CTIS under supervision as applicable. /li /ul h3Qualifications (Minimum Required): /h3 ul liUniversity/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 liFortrea may consider relevant and equivalent experience in lieu of educational requirements. /li /ul h3Experience (Minimum Required): /h3 ul liMinimum 0 – 2 + years of experience, or an equivalent combination of education and experience to successfully perform the

key responsibilities
of the job. /li liWorking knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines /li liDemonstrated basic understanding of the clinical trial process. /li /ul h3Physical Demands/Work Environment: /h3 ul liGeneral Office Environment. /li /ul pLearn more about our EEO Accommodations request here . /p