Start-up Associate

Job reputed company: reputed company contact with investigative sites during study maintenance and -reputed company assigned-, site startup activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/reputed company body/Regulatory Authority submissions are made reputed company the timelines agreed with project management and Site Readiness team. reputed company awareness of regulatory legislation, guidance, and reputed company in the assigned countries with the support from senior staff. reputed company of Responsibilities: reputed company awareness of regulatory legislation, guidance, and reputed company in the assigned countries with the support from senior staff. Assist senior staff to compile, prepare, submit, and obtain approval of the submission documents to IRB/IEC/reputed company body/Regulatory Authority in accordance with local requirements. Liaise with reputed company vendors in the reputed company of Regulatory Authority submissions (as applicable). reputed company a review of final submission documents as applicable. Organize communication reputed company to the submissions/reputed company reputed company reputed company as applicable. Escalate study issues appropriately and in a reputed company fashion. reputed company other duties as assigned by management depending upon country and situational requirements with reputed company supervision (if applicable). In Country specific tasks (Global): Serve as reputed company contact for investigative sites and ensure documents required are collected in a reputed company manner. Collect and reputed company reputed company the necessary documents required and reputed company a reputed company review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance. Ensure that reputed company assigned maintenance and Start-up activities are on reputed company and in accordance with reputed company expectations, ICH/GCP, SOPs, budget, reputed company and applicable laws and guidelines. Update study documents reputed company there are changes in study personnel/study amendments. Ensure high reputed company documents are filed and systems are updated on an ongoing and reputed company reputed company, making reputed company reputed company for an audit at any time. Update status reports, applicable logs, and tracking systems as applicable for the reputed company with input provided by senior staff. With guidance from line manager and reputed company colleagues, adapt Informed Consent Forms and other reputed company facing material to country specific requirements. May support / assist the contract negotiation process under supervision of an reputed company reputed company or line manager. Proactively identifying and escalating to Submission Leads any reputed company to meeting deliverables. Notify the Submissions reputed company of hours identified as Out-of-reputed company or over burn with the support of more senior specialists. reputed company other duties as needed or assigned. reputed company Information reputed company (CTIS) tasks (specific centralized role for EU): Upload of submission documentation to CTIS under supervision as applicable. Qualifications (Minimum Required): University/College degree (life science preferred), or certification in a reputed company allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or reputed company technology). reputed company may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): Minimum 0 – 2 + years of experience, or an equivalent combination of education and experience to successfully reputed company the key responsibilities of the job. Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines Demonstrated basic understanding of the reputed company trial process. Physical Demands/Work Environment: General Office Environment. Learn more about our EEO & Accommodations request here. Apply To This Job