FSO SSU(Guangzhou/Changsha) at Fortrea

Guangzhou City, Guangdong Province, China -

Full Time

Start Date

Immediate

Expiry Date

15 Mar, 26

Salary

0.0

Posted On

15 Dec, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Legislation, Clinical Trial Process, Document Submission, Quality Review, Communication, Problem Solving, Team Collaboration, Time Management, Attention to Detail, Informed Consent Forms, Contract Negotiation, Submission Documentation, Tracking Systems, Study Maintenance, Site Activation

Industry

Biotechnology Research

Description

Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll invite you for an interview. If you're pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your interest before moving forward with an offer Job Overview: Primary 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. Summary of Responsibilities: Develop awareness of regulatory legislation, guidance, and practice 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/Third body/Regulatory Authority in accordance with local requirements. Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable). Perform a review of final submission documents as applicable. Organize communication related to the submissions/outcomes within Fortrea as applicable. Escalate study issues appropriately and in a timely fashion. Perform other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable). In Country specific tasks (Global): Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner. Collect 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. Ensure 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. Update study documents when there are changes in study personnel/study amendments. Ensure high quality documents are filed and systems are updated on an ongoing and timely basis, making Fortrea ready for an audit at any time. Update status reports, applicable logs, and tracking systems as applicable for the projects with input provided by senior staff. With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements. May support / assist the contract negotiation process under supervision of an experienced colleague or line manager. Proactively identifying and escalating to Submission Leads any risk to meeting deliverables. Notify the Submissions Lead of hours identified as Out-of-Scope or over burn with the support of more senior specialists. All other duties as needed or assigned. Clinical Trials Information System (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 related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology). Fortrea 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 perform the key responsibilities of the job. Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines Demonstrated basic understanding of the clinical trial process. Physical Demands/Work Environment: General Office Environment. Learn more about our EEO & Accommodations request here. Didn’t find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life-saving therapies for patients worldwide. Follow us and stay updated about Fortrea on LinkedIn, Facebook, X, Instagram, YouTube and Glassdoor. At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.

Responsibilities

The primary responsibility is to serve as the main contact for investigative sites, ensuring timely collection and submission of essential documents. Additionally, the role involves assisting senior staff with regulatory submissions and maintaining compliance with local requirements.