Start-Up Associate

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

Responsibilities

• 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.
• 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.
• Clinical Trials Information System (CTIS) tasks (specific centralized role for EU): Upload of submission documentation to CTIS under supervision as applicable.

Requirements

• 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.

Preferred

• 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).

Physical Demands/Work Environment

General Office Environment. Learn more about our EEO & Accommodations request here .