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Centralized Study Spec Ii

2+ years
Not Disclosed
10 Oct. 24, 2024
Job Description
Job Type: Full Time Remote 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

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

Position Overview
Title: Clinical Study Coordinator
Location: Remote - USA

In this role, you will support the successful execution of clinical trials by following departmental Standard Operating Procedures (SOPs) and Work Instructions. Your responsibilities will include high-quality monitoring, reporting, and various tasks essential for study management.

Key Responsibilities

  • Monitoring and Reporting:
    Execute timely monitoring and reporting plans, including specialized monitoring requests for approved protocols.

  • Tool Implementation:
    Support the implementation of new monitoring tools and track metrics as determined by management.

  • Process Improvement:
    Proactively identify opportunities for process improvements and participate in their implementation.

  • Mentorship:
    Mentor and train team members to enhance their skills and performance.

  • Study Management:

    • Manage clinical systems and study documents, supporting eTMF management.
    • Resolve data management queries and maintain study databases (CTMS, IWRS, EDC).
    • Track outstanding issues with Clinical Research Associates (CRAs).
    • Generate study-specific reports and manage internal/external communications.
    • Assist in ensuring training compliance for study teams.
  • Financial Oversight:
    Manage study payments for sites and vendors, including payment reconciliation and release.

  • Documentation:
    Maintain Trial Master File (TMF) documentation, participate in TMF quality control, and ensure compliance metrics are met.

  • Project Tracking:
    Update timelines and milestones in project scheduling tools and escalate risks as needed.

  • Risk Management:
    Update the Xcellerate Risk Identification & Issue Resolution (XRIM) tool, following up on outstanding action items until resolved.

  • Project Planning:
    Draft or assist Functional Leads with project plans and coordinate feedback and execution between the study team and client.

  • Cross-Functional Collaboration:
    Facilitate communication and collaboration among study team members, attending and documenting meetings as required.

Additional Responsibilities

  • Vendor Oversight Management:
    Assist with oversight of vendors to ensure project requirements are met.

Why Join Fortrea?
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.

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 protected characteristics. We encourage all qualified individuals to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.

Visit Fortrea's website for more details.