Job Description

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
:• Primary contact with investigative sites during study maintenance and -when assigned-, site

start-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. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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