Job Overview
We are seeking a UK‑based Site Start‑Up (SSU) Specialist to join our high‑performing and collaborative team, supporting the delivery of early‑phase clinical trials (Phase I and Phase Ib). This role will work closely with Fortrea’s Clinical Research Unit (CRU) to drive combined review submissions and approvals, and ensure studies are set up efficiently and in line with regulatory requirements. The position offers a global perspective by contributing to U.S. submissions, activating Fortrea’s own clinical sites, and working across a wider network of research sites.
Summary of Responsibilities
* Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries.
* Coordinate, collect, and organize all data and information needed by EC/IRB/Third body/Regulatory Authority, including preparation of study documentation such as country application forms and cover letters for sponsor review.
* Compile and submit routine documents to IRB/IEC/Third body/Regulatory Authorities (e.g., INDs/CTAs) and liaise regarding submission and approval.
* Liaise with internal and external vendors in the generation of regulatory submissions.
* Review final submission documents for accuracy and completeness.
* Ensure all start‑up and maintenance activities remain on track, meet client expectations and budget, and comply with applicable laws, guidelines, regulatory requirements, ICH/GCP, SOPs, and quality standards.
* Prevent and promptly escalated study issues.
* Perform other duties as assigned by management, depending on country and situational requirements, with proper supervision when applicable.
* Country‑specific tasks (Global)
o Serve as primary contact for investigative sites, ensuring timely collection of required documents.
o Compile, format, and quality‑review final documents to enable effective and compliant site activation and maintenance without supervision.
o Keep documents and systems updated, ensuring Fortrea is ready for audit at any time.
o Participate in team and project meetings.
o Assist in defining site activation strategy, providing accurate projections and timelines.
o Review and customize country and site‑specific patient informed consent forms for local compliance.
o Resolve informed consent issues and other potential difficulties with study sites.
o Support negotiation of site contracts and budgets, track progress, and intervene or escalates as appropriate.
o Identify and escalated risks to meeting deliverables to Submission Leads.
o Notify Submission Leads of hours that are out‑of‑scope or overburn.
* CTIS tasks (centralized role for EU)
o Assist in uploading submission documentation to CTIS, interact with, and monitor all notifications and alerts to ensure milestones and events are met within mandated timelines.
* Perform all other duties as needed or assigned.
Qualifications (Minimum Required)
* University/College degree (life science preferred) or certification in a related allied health profession from an accredited institution (e.g., nursing certification, medical or laboratory technology) AND at least 2years of work experience in clinical research, including strong knowledge of the ICH guidelines and RA, IRB/IEC regulations.
* If the above educational requirement is not met, candidates with a High School Diploma or equivalent AND a minimum of 2years of experience in clinical research, with strong knowledge of the ICH guidelines and RA, IRB/IEC regulations, will be considered.
* Fortrea may consider relevant and equivalent experience in lieu of academic qualifications.
Experience (Minimum Required)
* Minimum of 2years of experience in clinical development or start‑up/regulatory process.
* Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines.
* Familiarity with investigator start‑up documents and contract/budget negotiation processes.
* Previous interaction with operational project teams and investigative sites.
* Demonstrated understanding of research protocol requirements and proven ability to communicate them and educate others.
Physical Demands / Work Environment
General office environment.
EEO & Accommodations
Learn more about our EEO & Accommodations request.
#J-18808-Ljbffr