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Senior Centralized Study Asso

2+ years
Not Disclosed
10 Oct. 30, 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

Company Overview

Fortrea is a leading global contract research organization (CRO) committed to scientific rigor and clinical development excellence. We offer pharmaceutical, biotechnology, and medical device clients a diverse 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.

Job Description

The Clinical Operations Coordinator will support day-to-day operational tasks and assist in ensuring the quality and productivity of clinical studies. This role involves managing clinical systems, maintaining study documents, and supporting the study team in various capacities.

Key Responsibilities

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

  • Daily Operations: Complete day-to-day tasks ensuring quality and productivity.

  • Metrics Tracking: Track and report metrics as determined by management according to required timelines.

  • Process Improvement: Participate in process improvement initiatives and assist with implementing revised processes and procedures.

  • Study Management Support:

    • Manage clinical systems and access management.
    • Oversee study documents and support eTMF management.
    • Maintain study databases (CTMS, IWRS, EDC, etc.).
    • Assist the study team with data review and support activities.
    • Track and follow up with CRAs for outstanding issues.
    • Generate study-specific reports.
    • Manage internal/external communications.
    • Ensure training compliance for study teams.
    • Manage study payments for sites and vendors.
  • Documentation and Compliance: Document and track study activities using relevant forms and tools. Maintain Trial Master File (TMF) documentation within the appropriate TMF platform, participate in TMF QC as assigned, and track/archive documents as applicable.

  • Project Health Monitoring: Actively support compliance metrics, including TMF, CTMS, and overall project health. Update timelines and milestones within project scheduling tools, CTMS, and other trackers, escalating any risks to timelines.

  • Risk Management: Update the Xcellerate Risk Identification & Issue Resolution (XRIM) tool and follow up on outstanding action items to resolution, including protocol deviations.

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

  • Team Collaboration: Facilitate study team communication and collaboration by organizing team meetings and documenting discussions, ensuring compliance with study requirements.

  • Vendor Management: Provide oversight for vendor management activities.

Join Us

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment to revolutionizing the development process ensures the swift delivery of life-changing therapies to patients in need. Join our exceptional team and thrive in a collaborative workspace that nurtures personal growth and enables 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 our 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, gender, sexual orientation, age, or any other legally protected characteristic. We encourage all to apply.

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