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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

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


Key Responsibilities:

  • Follow all applicable departmental Standard Operating Procedures (SOPs) and Work Instructions.
  • Complete daily tasks to ensure quality and productivity.
  • Track and report metrics as determined by management within required timelines.
  • Participate in process improvement initiatives and assist in implementing revised processes and procedures.
  • Manage clinical systems and access management.
  • Oversee study documents and support electronic Trial Master File (eTMF) management.
  • Maintain study databases (CTMS, IWRS, EDC, etc.).
  • Support study teams in data review and related activities.
  • Track and follow up with Clinical Research Associates (CRAs) on outstanding issues.
  • Assist in generating study-specific reports.
  • Manage internal and external communications.
  • Ensure training compliance for study teams.
  • Handle study payments for sites and vendors.
  • Document and track study activities using relevant forms and Project Management Systems.
  • Maintain Trial Master File documentation within the appropriate TMF platform and participate in TMF quality control.
  • Actively support compliance metrics related to TMF, CTMS, and overall project health.
  • Update timelines and milestones in project scheduling tools and escalate risks when necessary.
  • Utilize the Xcellerate Risk Identification & Issue Resolution (XRIM) tool to follow up on outstanding action items, including Protocol Deviations.
  • Draft or assist Functional Leads with project plans, coordinating reviews and feedback.
  • Collaborate with the Study Team to maintain WISER moments.
  • Facilitate team communication by attending and setting up meetings as needed.
  • Provide vendor management oversight as necessary.

Fortrea is seeking motivated problem-solvers and creative thinkers who share our commitment to overcoming barriers in clinical trials. Join our exceptional team and thrive in a collaborative environment that nurtures personal growth, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Equal Opportunity Employer:

Fortrea is proud to be an Equal Opportunity Employer (EOE/AA) that values diversity and inclusion. We do not tolerate harassment or discrimination and base employment decisions on business needs and individual qualifications. We encourage all qualified individuals to apply.

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