Site Contracts Roles
4 months ago
Description
: Primary contact with investigative sites during study maintenance and -when assigned-, sitestart-up 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. C. Essential Job Duties:
General tasks
¨ 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
Clinical Trials Information System (CTIS) tasks (specific centralized role for EU)
¨ Upload of submission documentation to CTIS under supervision as applicable
Minimum Required:
¨ Minimum 2 – 17 + 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
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
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