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. Conducting operations in 100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
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.
- 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.
- 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.
Qualifications (Minimum Required)
- 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.
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.
Physical Demands/Work Environment
- General Office Environment.
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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