The Start-up Associate at Fortrea plays a key role in clinical trial operations by supporting regulatory submissions and site startup processes. This position ensures compliance with ICH/GCP, SOPs, and applicable regulations while serving as the primary contact for investigative sites and internal stakeholders.
What You'll Do
- 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).
- 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.
- Upload of submission documentation to CTIS under supervision as applicable.
What We're Looking For
- 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.
- 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.
Work Mode
Onsite position.
Learn more about our EEO & Accommodations request here.
