Clinical Research Director - Indianapolis


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Clinical Research Director

Indianapolis, Indiana

 

As the state capital, Indianapolis is the most populous city in Indiana. Downtown Indianapolis boasts the largest employment cluster in Indiana, with nearly 43,000 jobs per square mile. With a low unemployment rate in Marion County, Indianapolis is a great area for talented healthcare professionals to live. Whether you prefer to work in a hospital, clinic, home care or senior housing setting—Greater Indianapolis job opportunities in healthcare are abundant.


On Time Talent Solutions is seeking a Clinical Research Director interested in overseeing, leading, and managing cross-functional team resources and external service providers.


Clinical Research Director Responsibilities:

  • Work with research leadership to develop clinical research strategic plans and objectives

  • Help develop best practices, methods, techniques, and operational standards for clinical research coordination at Nemours

  • Collaborate with Quality Assurance to develop quality plans for the conduct of clinical trials at Nemours

  • Develop, update, and maintain SOP’s for clinical research across all sites

  • Ensure federal regulations are followed and serve as subject matter expert for the submission of IND’s, and IDE’s at Nemours

  • Track, report, and review study quality metrics and identifies activities warranted to meet trial goals and timelines

  • Supervise clinical research core managers and leads across the Nemours enterprise

  • Write, prepare, and/or contribute to clinical protocols and amendments, ICFs, CRFs, study manuals and other clinical documents

  • Identify, qualify, audit, and manage all external vendors.. Take initiative to continually monitor each external vendor in performance management, escalate issues where appropriate, and make the appropriate changes in order to ensure trial conduct is completed in compliance and meets company’s business objectives.

  • Ensure clinical trial team and clinical trial sites are properly trained and in compliance protocols, drive site selection, and patient recruitment programs that deliver enrollment targets. Performs site monitoring with field team, as needed.

  • Responsible for ensuring the trial is “audit ready” at all times.


Clinical Research Director Qualifications:

  • Bachelor's degree required; Master's degree preferred

  • 5+ years supervising clinical research teams

  • RN Required

  • Familiarity with IND’s and IDE’s

  • Experience with research protocols and regulatory or governing bodies, including HIPAA and FDA regulations, IRB requirements, and Good Clinical Practices

  • Ability to Work collaboratively with cross functional internal groups/teams

  • Ability to create and manage internal and external budgets for research protocols

  • Experience with developing systems to manage/track productivity of clinical research functions

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