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Site Readiness And Reg Specialist Ii

3+ years
Not Disclosed
10 Jan. 28, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Site Readiness and Regulatory Specialist II

Category: Clinical
Job ID: 2443671
Locations: Available in 3 locations


About Fortrea

Fortrea is a global contract research organization (CRO) with a focus on scientific rigor and decades of clinical development expertise. Supporting pharmaceutical, biotechnology, and medical device clients, Fortrea offers clinical development and technology solutions across 20+ therapeutic areas. With over 18,000 employees operating in more than 90 countries, Fortrea is dedicated to transforming drug and device development for partners and patients worldwide.


Key Responsibilities

Regulatory Support and Compliance

  • Develop awareness of regulatory legislation, guidance, and practices in assigned regions/countries with support from senior staff.
  • Assist with clinical trial applications under the European Clinical Trials Regulation No 536/2014 in the Clinical Trials Information System (CTIS):
    • Complete Part I application details in CTIS.
    • Upload Part I and Part II documents accurately to CTIS.
    • Monitor CTIS and promptly notify the Global Regulatory Submissions Lead (GRSL) of alerts.
    • Ensure timely tracking of all submissions and approvals in applicable tracking tools.
    • Submit applications/notifications in CTIS with GRSL approval.

Quality Assurance and Document Management

  • Perform quality checks on submission documents, especially Part II applications, as delegated.
  • Upload final submission packages to the Trial Master File and perform functional reviews.
  • Ensure high-quality documents are filed, and systems are continuously updated for audit readiness.

Process Management and Communication

  • Initiate and manage the payment process for Part I and Part II submission fees.
  • Escalate study-related issues appropriately and in a timely manner.
  • Attend team and company meetings as applicable.
  • Perform additional duties as assigned by management depending on situational requirements.

Candidate Profile

Fortrea seeks motivated problem-solvers and creative thinkers who are passionate about overcoming barriers in clinical trials. The ideal candidate will:

  • Embrace a collaborative and growth-oriented workspace.
  • Be detail-oriented and capable of working under supervision.
  • Have a commitment to maintaining high standards of quality and regulatory compliance.

Why Join Fortrea?

  • Opportunity to contribute to the delivery of life-changing therapies to patients in need.
  • A collaborative and inclusive environment that fosters personal and professional growth.
  • The ability to make a global impact in clinical trials.

Equal Opportunity Employer

Fortrea is an Equal Opportunity Employer (EOE/AA) committed to diversity and inclusion in the workforce. Employment decisions are made based on qualifications and business needs, without discrimination based on race, religion, gender, age, disability, or any other legally protected characteristic.

For reasonable accommodation requests during the application or hiring process, contact taaccommodationsrequest@fortrea.com.

For more information, visit www.fortrea.com.