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Centralized Study Specialist I

3-7 years
Not Disclosed
10 July 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, 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

Fortrea, a leading global Contract Research Organization (CRO), is renowned for its scientific rigor and extensive clinical development expertise. We deliver a broad spectrum of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 professionals operating in over 90 countries, Fortrea is at the forefront of transforming drug and device development to benefit partners and patients worldwide.

Job Summary

We are seeking a dedicated professional to assist with the operations related to the setup, planning, and maintenance of clinical studies. This role involves supporting team members in delivering high-quality services to Sponsor-Investigators, either as part of project groups or as a standalone function. The successful candidate will ensure that all client interactions—both internal and external—meet our standards for quality, safety, and cost-effectiveness.

Essential Job Duties

  • Study Management: Oversee the setup, planning, and ongoing maintenance of clinical studies in the client portal.
  • Client Conventions: Maintain a thorough understanding of client-specific conventions or database requirements.
  • Reporting: Assist in generating monthly status and project-specific reports, ensuring data accuracy and quality.
  • Training and Support: Support, train, and mentor less experienced safety staff in all aspects of the role.
  • Compliance: Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), guidance documents, and directives.
  • Meeting Participation: Attend project team and internal meetings as required.
  • Archiving: Prepare and coordinate the archiving of ISR study files upon project completion.
  • Investigator Updates: Ensure that investigators provide necessary study updates, including regulatory updates and enrollment data, and manage the transfer of safety information to customers.
  • Protocol and Study Design: Follow up regularly with customer Points of Contact (POCs) regarding protocol/study design updates, and track progress with investigator sites.
  • Milestone Management: Ensure that contractual milestones are met, and escalate any issues or delays to customers.
  • eTMF Compliance: Monitor eTMF compliance based on the filing plan and provide guidance to investigator site staff via the client communication portal.
  • Drug Supply Forecasting: Validate initial drug supply needs based on the investigator’s enrollment plan and provide forecasting updates to clients.
  • Governance Support: Assist with presentations for customer governance calls.
  • Additional Duties: Perform other tasks as assigned by management.

Join Our Team

Fortrea is looking for innovative problem-solvers and creative thinkers who are passionate about overcoming challenges in clinical trials. We are committed to revolutionizing the development process to ensure the swift delivery of life-changing therapies to patients. Join us in a collaborative work environment that fosters personal growth and enables 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. We are committed to diversity and inclusion in our workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are made based on business needs and individual qualifications, without regard to race, religion, color, national origin, gender (including pregnancy and other medical conditions), family or parental status, marital status, sexual orientation, gender identity or expression, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all qualified individuals to apply.

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