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.
• Assistseniorstaff 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.
• Clinical Trials Information System (CTIS) tasks (specific centralized role for EU):
• Upload ofsubmission documentation to CTIS under supervision as applicable.
• All other duties as needed or assigned.
Qualifications(Minimum Required):
• Bachelor 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).
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