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Centralized Study Spec I

2+ years
Not Disclosed
10 Oct. 24, 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

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

Key Responsibilities

  • Compliance:
    Follow all applicable departmental Standard Operating Procedures (SOPs) and Work Instructions.

  • Task Management:
    Complete day-to-day tasks with a focus on quality and productivity.

  • Monitoring Plans:
    Execute high-quality, timely monitoring and reporting plans, including specialized monitoring requests for approved protocols.

  • Metrics Tracking:
    Track and report metrics as defined by management, proactively identifying opportunities for process improvements and participating in their implementation.

  • Mentorship:
    Provide mentorship and training to team members.

  • Study Management:
    Assist with managing clinical systems, study documents, and eTMF management, while maintaining study databases (CTMS, IWRS, EDC, etc.).

  • Issue Resolution:
    Track and follow up with Clinical Research Associates (CRAs) for outstanding issues and support the generation of study-specific reports.

  • Communications:
    Manage internal and external communications, ensuring training compliance for study teams and assisting with study payments (site and vendor).

  • Documentation:
    Document and track study activities using relevant forms and Project Management Systems, including data related to Clinical, SU, and VM.

  • Leadership Role:
    Centralized Study Specialists I are expected to take a leadership role in ensuring successful partnerships with support groups, helping to remove barriers and facilitate success.

  • Trial Master File (TMF) Management:
    Maintain TMF documentation, participate in TMF quality control as assigned, and track/archive documentation as applicable.

  • Collaboration:
    Facilitate study team communication by organizing team meetings and documenting discussions as per study requirements.

  • Vendor Oversight:
    Provide oversight of vendor management.

  • Project Support:
    Assist in drafting project plans, coordinating reviews, feedback, and execution between study teams and clients.

  • Timeline Updates:
    Update timelines and milestones within MS Project, CTMS, and other trackers, escalating risks when timelines are at risk.

Fortrea's Commitment

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment is to revolutionize the development process, ensuring the swift delivery of life-changing therapies to patients in need. Join our exceptional team and embrace a collaborative workspace that nurtures personal growth, 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. We encourage all qualified individuals to apply.

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Visit Fortrea's website for more details.