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. Job Overview: Fortrea is currently seeking a proactive Start-up Specialist to join our client-dedicated Team. Are you a detail-oriented professional with experience in clinical research and regulatory processes? Join our team as a Start-up Specialist and play a key role in site activation for clinical trials Summary of Responsibilities: ✔ Serve as a primary contact expert for a dedicated Client, to perform Country Level start-up and maintenance activities/amendments of Clinical Trials in the UK (ROI applications knowledge also useful, but not essential). ✔ Collaborate effectively to collect, review, prepare and manage all essential documentation necessary for submissions to UK ethics an regulatory authorities. ✔ Ensure timely and compliant submissions to EC/IRB/Third body (e.g ARSAC)/Regulatory authorities in the relevant systems, predominantly UK Combined Review. ✔ Maintain knowledge of submission regulatory standards and provide expert guidance on start-up processes. ✔ Confidently support QC activities of applications before submissions. ✔ Track submission milestones, meet strict client deadlines and KPIs. Escalate issues and ensure audit readiness. ✔ Collaborate with project teams, Chief Investigators and mentor junior colleagues as needed. What We are looking for: Education: Bachelor's degree in life sciences or related field (or relevant equivalent experience). Experience: At least 2 years in clinical research, with knowledge of ICH guidelines and regulatory requirements. Experience in country set up and maintenance of Oncology Trials is desirable Strong understanding of CT start-up documentation, Country Level start-up and maintenance activities including submission processes and relevant systems within the UK. Knowledge of the full functionality of Combined Review processes for both Ethics (SIF) and Regulatory (MIF and Section D) is desirable, although mentoring will be available for candidates with a main expertise in one of these areas. Excellent organizational, communication and problem-solving skills. Basic knowledge and familiarity with Clinical Trials Information System (CTIS) processes (EU-specific roles), would be useful but not currently essential in this role. Ready to make a difference? Apply today Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com . Fortrea is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply. For more information about how we collect and store your personal data, please see our Privacy Statement . If, as a result of a disability, you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: taaccommodationsrequestfortrea.com . Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application.
