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Clinical Trials Operations Specialist

2 months ago

Washington, United States George Washington University Full time
Position Overview

The George Washington University School of Medicine and Health Sciences is seeking a dedicated Clinical Trials Operations Specialist to join our esteemed GW Vaccine Research Unit (GW VRU). This role is pivotal in advancing our mission to conduct Phase I-III clinical trials aimed at developing innovative vaccines for infectious diseases.

Key Responsibilities:

The selected candidate will be instrumental in supporting the clinical research team through various essential functions, including but not limited to:
  • Overseeing daily study operations and assisting the research team in all facets of clinical trial activities.
  • Facilitating participant recruitment; evaluating the eligibility of potential subjects and coordinating appointments; contributing to the formulation and execution of recruitment strategies.
  • Maintaining comprehensive study documentation, training records, and investigator site files.
  • Preparing submissions for the Institutional Review Board (IRB) and other regulatory entities.
  • Creating technical research documents such as consent forms, case report forms, study protocols, and technical reports.
  • Conducting data entry and management using various clinical trial management systems.
  • Engaging with sponsors, monitors, and other collaborators involved in the study.
  • Performing monthly chart audits to ensure quality assurance and control.
  • Participating in study meetings; documenting minutes and agendas.
  • Assisting in the development and revision of standard operating procedures (SOPs).
  • Managing invoices, supply orders, and inventory as needed.
  • Ensuring adherence to all regulations governing clinical trials, including human research subject protections and Good Clinical Practice.

Qualifications:

Ideal candidates will possess a BA/BS degree and a minimum of two years of relevant experience. Certification in a related field is preferred.

Preferred Skills:
  • Strong verbal and written communication abilities.
  • Exceptional interpersonal, organizational, and problem-solving skills.
  • Attention to detail, initiative, and the capacity to manage multiple tasks effectively.
  • Experience in clinical research or project management.
  • Proficiency in Microsoft Office and clinical trial management software.

Compensation and Benefits:

The position offers a competitive salary range and a comprehensive benefits package, including medical, dental, vision, life and disability insurance, retirement savings, and tuition assistance.

Work Environment:

This is a full-time position requiring on-site work, with a standard work schedule from Monday to Friday. The successful candidate will be part of a collaborative and dynamic research environment dedicated to advancing public health through innovative vaccine research.