U

University of Pennsylvania

Ivy League university in Philadelphia, PA

Clinical Research Project Manager

Clinical Research OperationsPosted on Nov 11
Full-timePhiladelphia, PA, USA$63.1k - $74.5k /yrIn-person

About the Job

Requirements

  • A bachelor's degree and 3–5 years of related experience, or an equivalent combination of education and experience, are required.
  • Knowledge of REDCap is required.
  • Prior experience recruiting is required.

Responsibilities

  • With supervision, manage single- and/or multi-site clinical research projects, including study start-up, daily operations, external site communications, recruitment and enrollment, troubleshooting, quality assurance and quality control, and study close-out activities. Conduct study visits and procedures when needed to meet project needs.
  • Develop, create, and review regulatory submissions and study documents and tools, including protocols, consents, annual reports, source documents, training slides, manuals of procedures, Data Safety Monitoring Board charters, case report forms, and standard operating procedures. Assist with investigational new drug, investigational device, and clinical trial agreement exemption determinations.
  • Assist with or conduct pre-award finance activities, including medical record abstraction, Medicare coverage analysis development, clinical trials management system registration, research billing numbers, driving contract timelines, budgeting input or development, and grant-writing assistance; and/or post-award finance activities, including invoicing and billing review.
  • Assist and train direct and/or indirect clinical research staff in program, division, or department procedures as required by protocols. This includes onboarding, data and lab management, protocol compliance, quality control, quality assurance, human subjects protection, good clinical practice, project assignments, staff mentoring, and completion of biannual performance appraisals.
  • Perform additional duties as assigned.

About the Company

University of Pennsylvania

Ivy League university in Philadelphia, PA

The University of Pennsylvania is a private Ivy League research university in Philadelphia. It comprises twelve undergraduate, graduate, and professional schools, including the Wharton School, Perelman School of Medicine, and Penn Carey Law.

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