Site Readiness And Reg Specialist Ii

0-2 years

Not Disclosed

Bangalore Mumbai Pune

10 Jan. 18, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Position: Site Readiness and Regulatory Specialist II
Location: Available in 3 locations
Category: Clinical
Job ID: 2443671

Job Overview

Fortrea is looking for a Site Readiness and Regulatory Specialist II to support regulatory submissions and clinical trial applications in compliance with European Clinical Trials Regulation No 536/2014. You will work closely with the Global Regulatory Submissions Lead (GRSL) and contribute to activities such as preparing clinical trial application documents, monitoring submissions, and ensuring timely and accurate tracking of approvals.

Key Responsibilities

Regulatory Knowledge: Develop an understanding of regulatory legislation, guidance, and practices within assigned regions and countries under the guidance of senior staff.
Clinical Trial Application Support:
- Complete Part I application information and upload necessary documents to Clinical Trial Information System (CTIS).
- Initiate the payment process for submission fees and seek approval from the GRSL.
- Monitor CTIS alerts and inform GRSL of any updates.
- Ensure timely and accurate tracking of submissions and approvals in applicable tools.
- Perform functional reviews and submit applications/notifications in CTIS with GRSL's permission.
Documentation and Quality Control:
- Upload final submission packages to the Trial Master File (TMF) and ensure high-quality documents are filed in a timely manner.
- Perform QC of Part II applications and final submission documents as delegated.
Issue Escalation: Escalate study issues in a timely manner and ensure Fortrea is always audit-ready.
Collaboration and Meetings: Attend team and company meetings as required and perform other duties assigned by management.

Required Qualifications

Experience: Some experience in regulatory submissions and clinical trial applications is preferred.
Skills:
- Understanding of regulatory processes and experience with Clinical Trial Information System (CTIS).
- Strong attention to detail and ability to handle multiple tasks efficiently.
- Excellent communication skills and ability to collaborate with teams.
Adaptability: Ability to perform duties as assigned, with supervision as needed.

Company Overview

Fortrea is a global contract research organization (CRO) specializing in clinical development and technology solutions across more than 20 therapeutic areas. With over 18,000 employees and operations in 90+ countries, Fortrea is dedicated to transforming drug and device development, providing life-changing therapies to patients worldwide.

Equal Opportunity Employer Statement

Fortrea is an Equal Opportunity Employer that encourages diversity and inclusion in the workforce. We do not tolerate harassment or discrimination and make employment decisions based on individual qualifications and business needs.

Accommodation

Fortrea provides reasonable accommodations for individuals requiring assistance during the hiring process. Please contact taaccommodationsrequest@fortrea.com for accommodation requests.

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Site Readiness And Reg Specialist Ii

Job Description

Job Overview

Key Responsibilities

Required Qualifications

Company Overview

Equal Opportunity Employer Statement

Accommodation

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