Job Overview
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe. Key Responsibilities:
Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries. Coordinate, collect and organize data and information required by EC/IRB/Third body/Regulatory Authority including but not limited to the preparation of study documentation such as the country application form and cover letter for sponsor review as applicable. Compile and prepare routine submission filed to IRB/IEC/Third body/Regulatory Authorities (e.g., INDs/CTAs) and liaise with them as applicable regarding submission/approval. Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable). Perform a review of final submission documents as applicable. Ensure that 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, regulatory requirements, ICH/GCP, SOPs and quality standards. Prevent and escalate study issues appropriately and in a timely fashion. Estimated Salary: $80,000 - $120,000 per year Requirements
University/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) Minimum 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations Language: English
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe. Key Responsibilities:
Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries. Coordinate, collect and organize data and information required by EC/IRB/Third body/Regulatory Authority including but not limited to the preparation of study documentation such as the country application form and cover letter for sponsor review as applicable. Compile and prepare routine submission filed to IRB/IEC/Third body/Regulatory Authorities (e.g., INDs/CTAs) and liaise with them as applicable regarding submission/approval. Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable). Perform a review of final submission documents as applicable. Ensure that 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, regulatory requirements, ICH/GCP, SOPs and quality standards. Prevent and escalate study issues appropriately and in a timely fashion. Estimated Salary: $80,000 - $120,000 per year Requirements
University/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) Minimum 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations Language: English
