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Senior Centralized Study Asso

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 dedicated 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.

  • Quality Management:
    Complete day-to-day tasks ensuring high quality and productivity.

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

  • Process Improvement:
    Participate in process improvement opportunities and assist with the implementation of revised processes and procedures.

  • Study Management:
    Manage clinical systems and access management, oversee study documents, and support eTMF management.

  • Database Maintenance:
    Maintain study databases (CTMS, IWRS, EDC, etc.) and support the study team in data review.

  • Issue Tracking:
    Track and follow up with Clinical Research Associates (CRAs) for outstanding issues and support in generating study-specific reports.

  • Communication Management:
    Manage internal and external communications and assist in ensuring training compliance for study teams.

  • Payment Management:
    Manage study payments for sites and vendors.

  • Documentation:
    Document and track study activities using relevant forms and Project Management Systems, with guidance and support.

  • TMF Management:
    Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF quality control as assigned, and track/archive documentation as applicable.

  • Compliance Support:
    Actively support compliance metrics, including TMF, CTMS, and overall project health.

  • Timeline Updates:
    Update timelines and milestones within project scheduling tools and escalate any risks to timelines.

  • Issue Resolution:
    Update the Xcellerate Risk Identification & Issue Resolution (XRIM) tool and follow up on outstanding action items, including Protocol Deviations.

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

  • WISER Moments:
    Work with the study team to maintain WISER moments.

  • Meeting Facilitation:
    Facilitate study team communication by attending and setting up team meetings for all functions as needed.

  • Vendor Oversight:
    Provide oversight for vendor management.

Fortrea's Commitment

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 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.