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Centralized Study Specialist I

2+ years
Not Disclosed
10 Oct. 29, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Opportunity: Clinical Study Coordinator

Company: Fortrea
Location: [Insert Location]
Job Type: [Insert Job Type]

Company Overview

As a leading global contract research organization (CRO), Fortrea is dedicated to scientific rigor and boasts decades of clinical development experience. We offer a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in over 90 countries, Fortrea is transforming drug and device development for partners and patients worldwide.

Role Overview

Fortrea is actively seeking a motivated Clinical Study Coordinator to support clinical operations. This role encompasses a variety of tasks related to managing clinical systems, study documents, and data management queries, while ensuring compliance with regulatory requirements and best practices.

Key Responsibilities

  • Clinical Systems Management: Oversee the management of clinical systems, including CTMS, IWRS, and EDC.
  • Study Documentation: Manage study documents and support eTMF management.
  • Data Management Support: Assist study teams in resolving data management queries and tracking outstanding issues with CRAs.
  • Reporting: Generate study-specific reports and review study performance dashboards.
  • Internal/External Communication: Manage communications with internal teams and external stakeholders.
  • Training Compliance: Assist in ensuring training compliance for study teams.
  • Study Payments: Manage site and vendor payments, including reconciliation and release.
  • Data Review: Follow up with CRAs on outstanding issues, draft study-specific reports, and collaborate with data management and programming teams.
  • Document Review: Ensure compliance of investigator packages, informed consent forms, and patient recruiting materials with regulatory requirements and GCP guidelines.
  • Quality Assurance: Perform checks to ensure quality of completed work and support the implementation of new monitoring tools.
  • Process Improvement: Identify opportunities for process enhancements and lead improvement activities.
  • Mentoring: Mentor and train junior team members as needed.

Qualifications

  • Experience in clinical study coordination or related field.
  • Strong understanding of regulatory requirements and Good Clinical Practice (GCP).
  • Excellent organizational skills with the ability to manage multiple studies simultaneously.
  • Strong communication skills, both oral and written.

Why Join Fortrea?

At Fortrea, we are committed to revolutionizing 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, allowing you to make a meaningful global impact.


Equal Opportunity Employer

Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to race, religion, color, national origin, gender, family status, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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